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Tumukunde, Isaac Sekitoleko, Charles Opondo, Moffat Nyirenda, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5313012/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 09 Apr, 2025 Read the published version in BMC Pediatrics → Version 1 posted 10 You are reading this latest preprint version Abstract Background Studies evaluating the impact of kangaroo mother care (KMC) on neonatal mortality and morbidity often rely on healthcare worker records or caregiver reports to measure intervention duration. However, the accuracy of these methods remains uncertain. We examined the validity of different methods of KMC duration measurement amongst neonates ≤ 2000g in Uganda. Methods This observational study was embedded within the OMWaNA trial, which examined the impact of KMC on neonatal mortality before clinical stability. An independent observer (considered the gold standard) monitored neonates every 2 hours to confirm KMC position, using an Android tablet-based application adapted from the EN-BIRTH study. The gold standard was compared to routine healthcare workers charting and caregiver diary reports of KMC. Results Among 222 caregiver-newborn pairs, 219 initiated KMC. The mean daily KMC duration recorded by the gold standard was 8·4 hours (SD 3·5). Healthcare workers reported an average of 8·5 hours (SD 4·0), while caregivers reported 10·4 hours (SD 3·8). The mean difference was 0·2 hours less for healthcare workers (95% CI -0·3 to 0·6) and 1·7 hours more for caregivers (-2·1 to -1·3) compared to the gold standard. Agreement rates for individual KMC episodes were 55·2% (95% CI 54·4–55·9) for healthcare workers and 58·2% (57·2–59·0) for caregivers. Participants with a helper (substitute KMC provider) had longer daily duration compared to those without (mean difference 1·89 hours [0·89 − 2·84]; p < 0·001). Conclusion Healthcare worker records provide a reasonably accurate estimate of KMC duration at the population level, supporting the integration of KMC indicators into national health information systems to facilitate monitoring and evaluation. Presence of a helper increases KMC duration, underscoring the need for research to identify strategies to increase family involvement. Kangaroo mother care low-birth-weight neonate prematurity Validation Figures Figure 1 Figure 2 RESEARCH IN CONTEXT Evidence before this study: Kangaroo mother care (KMC) improves survival of low birthweight neonates, with longer daily KMC duration linked to lower mortality risk. However, analyses of KMC duration remain unclear, partly due to the variability and unknown accuracy of measurement methods. Studies have traditionally relied on healthcare workers records or caregivers reports to assess KMC duration. We searched PubMed, without language restrictions, for published studies on validation of KMC duration measurement methods from Jan 1, 1990, to 21 November 2022, using the following search terms: “kangaroo mother care” [MeSH], or “care method, kangaroo mother” [MeSH], or “skin-to-skin contact” [MeSH], or “skin-to-skin care” [MeSH], and “monitoring,” or “ measurement,” or “duration”. We found that the majority KMC studies relied on caregiver (54%) and healthcare worker records (31%) to measure KMC duration, with no reported validation of the methods. Added value of this study: This study is the first published validation of the accuracy of KMC duration measurement methods, comparing healthcare worker records and caregiver reports against direct observation (considered the gold standard) using a time-stamped app. The findings demonstrate that, while healthcare worker records closely match the gold standard with a minimal mean difference of 0·2 hours lower, caregiver reports tend to overestimate KMC duration by an average of 1·7 hours. The study also highlights the benefit of having a helper (substitute KMC provider), with an additional 1·89 to 2·03 hours of KMC daily, depending on adjustments for maternal factors. Implications of all the available evidence: The reasonable accuracy of healthcare worker recording of KMC duration supports wider use, potentially in national health information systems, facilitating more reliable monitoring and evaluation of quality of KMC implementation. However, the lower agreement rates suggest the need for improved training and standardisation of reporting tools to enhance KMC duration measurements by healthcare workers. Caregiver reports are useful for tracking KMC coverage but should be interpreted cautiously when assessing KMC duration, especially in the absence of healthcare worker records. Our research also contributes more robust evidence to underscore the value of involving family members to increase the duration and effectiveness of this life-saving intervention. INTRODUCTION Globally, 2·3 million neonatal deaths (first 28 days after birth) were estimated to occur in 2022( 1 ). Small vulnerable newborns (SVN), including those born preterm and small-for-gestational age, account for more than half of neonatal deaths, plus have an increased risk for post neonatal mortality and growth failure ( 2 , 3 ). Mortality risk is highest in low- and middle-income countries (LMIC) due to gaps in coverage and quality of neonatal care ( 4 ). Improving the care of small and sick neonates in hospitals is crucial to accelerating neonatal survival and meeting Sustainable Development Goals (SDGs) by 2030 ( 2 , 5 ). Kangaroo mother care (KMC) involves early and prolonged skin-to-skin contact (SSC), promotion of exclusive breastfeeding or breastmilk feeding, and follow-up after discharge. KMC is associated with decreased mortality, sepsis, hypothermia, hypoglycaemia, and length of hospital stay compared to conventional care among clinically stable neonates ( 6 – 8 ). A meta-analysis of three trials of KMC initiated before stabilisation showed a 19% relative reduction in neonatal mortality at 28 days ( 9 ). KMC is recommended by the World Health Organisation (WHO) to be initiated as soon as possible after birth in all neonates weighing < 2500 grams (g) ( 10 ). Longer durations of KMC are crucial for achieving positive health outcomes ( 8 , 11 , 12 ). Research indicates that KMC only reduces mortality in stable neonates when provided for 20 hours or more daily, according to a Cochrane review (2016) ( 6 ). A more recent review reported significant reduction in mortality at 28 days when the daily duration was at least 8 hours ( 12 ). Conversely, another systematic review highlighted that some benefits of KMC are lost when the KMC duration is 2 hours or less ( 13 ). The OMWaNA trial in Uganda showed that neonates in the intervention group who received a median of 12–24 hours of KMC per day had a lower risk of mortality at 7 days and 28 days compared to those receiving < 12 hours per day ( 9 ). Although the WHO recommends 8–24 hours of KMC daily, this guideline is based on a systematic review that highlighted a lack of sufficient data on the optimal duration of KMC ( 12 ). The absence of reliable and validated methods to measure KMC duration complicates the interpretation of evidence from meta-analyses that combine studies with varying KMC measurement methods ( 6 ). Barriers to higher duration of KMC have been reported at both the health facility and community level. Studies have found that lack of beds and space, privacy issues, inadequate caregiver education, insufficient staff and monitoring devices, and difficulties motivating mothers to devote time were common barriers to KMC continuity in health facilities ( 14 – 16 ). Maternal factors, such as fatigue, depression, and postpartum pain, especially after a caesarean section, may reduce uptake and the time spent in the KMC position ( 17 ). Women may find long hours of KMC challenging, impeding sleeping and eating, or after discharge, affecting time for household activities ( 17 ). Our recent scoping review found 54 studies reporting on KMC duration. Of these, the majority of studies (29, 54%) used caregiver reports and a few (17, 31%) have used healthcare worker records to measure the duration of the intervention( 18 ). However, evidence on the validity of these methods to accurately measure KMC duration is lacking. One previous study in Tanzania, Bangladesh and Nepal validated the coverage indicator of KMC and measured duration using a time-stamped app but did not validate the measurement of duration ( 19 ). Although it is plausible that longer durations of KMC improve health outcomes amongst neonates, the evidence remains incomplete without more rigorously validated methods for measuring the duration of KMC. The aim of this study was to evaluate the validity of different methods for measuring KMC duration, compared to the gold standard of direct observation, among admitted newborns weighing ≤ 2000g in Uganda. METHODS Study design, settings, and population This was an observational validation study embedded in the OMWaNA trial, a randomised, controlled trial examining the effect of KMC initiated prior to clinical stability on neonatal mortality, relative to standard care, in Uganda (20). The trial recruited between October 2019 and July 2022 in five hospitals across Uganda. Neonates recruited to the trial between October 2021 and July 2022 at the largest trial site, Kawempe National Referral Hospital in Kampala, were included in this KMC duration measurement validation sub-study (9). Participants included singleton, twin, or triplet (if triplet pregnancy resulted in demise of ≥1 fetus) neonates born weighing 700-2000g who were randomised to the intervention (KMC) arm of the trial, and their caregivers. Neonates with life-threatening instability (defined as oxygen saturation <88% while on oxygen support, and ≥1 of heart rate 200 beats/minute, respiratory rate 100 breaths/minute apnoea requiring bag-mask ventilation), jaundice requiring immediate treatment, active seizures, or major congenital malformation were excluded from the study. Study Procedure s KMC was initiated as soon as possible following recruitment into the trial. Neonates were placed onto the exposed chest of their caregiver skin-to-skin using a KMC wrap. Prior to placing neonates in the KMC position, a study nurse or medical officer demonstrated to caregivers how to perform KMC, breastfeed, and feed the baby expressed breastmilk. An independent observer (considered the gold standard) monitored neonates every 2 hours around the clock to record-time stamped data documenting if they were in the KMC position, as done in the EN-BIRTH KMC coverage indicator validation study (19). They also documented the KMC provider (mother or substitute provider) and reason for not performing KMC if it was not being practiced at the time of observation. Data were collected using a custom-built Android tablet-based software application adapted from the EN-BIRTH study (19). During routine nursing observations (every three hours), a study nurse (healthcare worker record) documented whether neonates were in the KMC position. Caregivers were provided with a “diary” in terms of paper chart and a pen, and a study nurse demonstrated how to record the start and end time of each episode of KMC (caregiver report). Illiterate caregivers were assisted to report by a literate caregiver participant. Results are reported in accordance with STROBE statement checklist for cross-sectional studies (appendix 1). Sample size The sample size for the sub-study was 222 caregiver-baby pairs. This sample size provided 80% power to detect a difference of at least 0·96 hours in the mean daily duration of KMC, assuming an expected daily mean of 8 hours and a standard deviation (SD) of the difference in any pairwise comparison of 5·1 hours. Data analysis Participants social demographic characteristic where summarised using frequencies and proportions. We calculated healthcare worker-recorded and caregiver-reported duration of KMC and compared them with the independent observer’s documented KMC duration as means. To assess the accuracy of population level performance, we independently calculated and compared the gold standard observation with the healthcare worker record and caregiver-reported KMC duration for all mother-baby pairs using Bland-Altman plots. At individual level, point observations/records of KMC practice for the two methods were compared with the gold standard and validity “diagnostic test” methods were calculated using two-way tables, excluding missing pairwise data. Sensitivity, specificity, and positive predictive values were calculated for the two methods. A logistic regression model was applied to estimate the difference in KMC duration between the participants with a helper (substitute KMC provider) and those without. Stata version 18 (College Station, TX, USA) was used for all quantitative analyses. RESULTS A total of 222 mother-baby pairs were enrolled, among which 219 initiated KMC. Three babies never started KMC due to worsening clinical conditions. About half of the newborns were male (Table 1 ). The mean gestational age at screening was 32 weeks (SD 2·5; 95% [CI] 26–38) and the mean birthweight was 1·5kg (SD 0·3; 95% [CI] 0·8 − 2·0. Most women were aged 23–34 years of age and were married or cohabiting (Table 1 ). Table 1 Characteristics of newborns and their mothers Variable % (n/N) Mothers Age (years) 35 7.3% (16/219) Mode of delivery Normal spontaneous vaginal delivery 88.7% (196/221) Caesarean delivery 9.9% (22/221) Forceps or vacuum-assisted vaginal delivery 1.4% (3/221) Employment status, n (%) ^ Formal employment 20.4% (45/221) Informal employment 34.4% (76/221) Unpaid labour 45.2% (100/221) Neonates Male sex 50.7% (111/219) Gestational age * at screening (weeks), mean (SD) 32 (2.5) Birthweight (kg), mean (SD) 1.5 (0.3) Birthweight distribution (g), n (%) 700 to < 1000 3.2% (7/220) 1000 to < 1500 35% (77/220) 1500 to 2000 61.8% (136/220) * Gestational age calculated by Ballard score. ^ Formal employment includes work for the government, the private sector, or non-governmental organisations. Informal employment includes work for private households, self-employment, and work on a farm or with livestock. Unpaid labour includes unemployment, student, home maker, and retired. Caregivers reported 14,031 (77·5%) episodes in which the newborn was in the KMC position. Healthcare workers recorded 9,574 (53·1%) observations in which the newborn was in the KMC position. The independent observer reported 9,321 (51·1%) observations in which the newborn was in the KMC position. The KMC provider was a substitute caregiver (not the mother) in 2,455 (26·3%) observations by the independent observer in which the newborn was in the KMC position. The majority of substitute KMC providers were female relatives of the newborn, including auntie (51·6%) followed by grandmother (22·5%). Others included siblings (11·2%), fathers (11·1%), uncle (6·5%), and friend of the mother (0·7%). For 8,905 observations by the independent observer, newborns were not in KMC position. The reasons for not doing KMC were recorded for 8,250 (92·6%) observations. Caring for the newborn (including feeding, cleaning and medical care) was the main reason at 59·6% followed by caregiver self-care (bathing and having meals). Others included caregiver fatigue (8·1%), caregiver doing other cores (5·1%), newborn ill-health (4·0%) and care giver ill-health (1·5%). The mean cumulative KMC duration reported by independent observers was 67·8 hours (SD 64·6), with a mean daily duration of 8·4 hours (SD 3·5). Caregivers reported a mean cumulative KMC duration of 82·6 hours (SD 68·6) and a mean daily duration of 10·4 hours (SD 3·8), while healthcare workers recorded a mean cumulative KMC duration of 60·5 hours (SD 34·4) and a mean daily duration of 8·5 hours (SD 4·0) (Table 2 ; Fig. 1). Table 2 Cumulative and daily mean duration of KMC and validation test outcomes Cumulative duration of KMC (hours), mean (SD) Cumulative difference between methods and observer (hours), mean (SD) Daily KMC duration (hours), mean (SD) Daily difference between methods and observer (hours), mean (SD) Sensitivity (95% CI) Specificity (95% CI) Positive predictive value (PPV) Percent agreement * Observer (gold standard) 67·8 (64.4) - 8·4 (3·5) - - - - - Healthcare worker record † 60·5 (34.4) 9·5 8·5 (4·0) 0·2 52·6 (51·9–53·3) 59·1 (58·3–59·8) 57·6 55·7% Caregiver report ^ 82·6 (68.6) -14·1 10·4 (3·8) -1·7 85·1 (84·5–85·6) 30·5 (29·9–31·2) 56·4 58·6% Using the mean cumulative KMC duration to assess the level of agreement between the methods, the mean difference between independent observer and healthcare worker record was 9·5 (95% CI 3·5 to 15·5), implying that healthcare workers recorded KMC duration 9·5 hours shorter over the period of observation. The mean difference between independent observer and caregiver reports was − 14·1 (95% CI -17·6 to -10·6), meaning that caregivers reported KMC duration 14 hours longer over the period of observation. Using the mean daily KMC duration to assess the level of agreement between the methods, the mean difference between independent observer and healthcare worker records was 0·2 (95% CI -0·3 to 0·6; Fig. 2A). The mean difference between independent observer and caregiver report was − 1·7 (95% CI -2·1 to -1·3; Fig. 2B). The percentage agreement between independent observers and the two measurement methods were 55·7% for healthcare workers and 58·6% for caregivers (Table 2 ). Healthcare worker record had a sensitivity of 52·6% and a specificity of 59·1%, while caregiver report had a sensitivity of 85·1% and a specificity of 30·5%. The two methods had low positive predictive values of 57·6% and 56·4% for healthcare worker record and caregiver report, respectively. About two-thirds (n = 149, 67·1%) of participants had a helper during the hospital stay who acted as a substitute KMC provider in the place of the mother, accounting for 2,455 (26·3%) observations. Participants with a substitute KMC provider had a mean daily KMC duration of 9·8 hours (SE 0·3) compared to 7·9 hours (SE 0·4) for those who did not have a substitute KMC provider (mean difference 1·9 hours; 95% CI 0·9 − 2·8; p < 0·001). After controlling for maternal age, parity, marital status, and employment category, the adjusted mean difference in daily KMC duration increased to 2·0 hours (95% CI 1·0–3·0; p < 0·001). Discussion This is the first study to test the validity of healthcare worker record and caregiver report for KMC duration measurement, compared against independent observers as a “gold” standard using a time-stamped app. Our findings demonstrate that while healthcare worker records closely match the gold standard with a minimal mean difference of 0·2 hours lower, caregiver reports tend to overestimate KMC duration by an average of 1·7 hours. The study also highlights the significant impact of having a substitute KMC provider, with participants benefiting from an additional 1·9 to 2·0 hours of KMC daily. Our results suggest that healthcare worker records can provide a relatively accurate estimate of KMC duration at the population level. These records could be integrated into national health information systems to support the monitoring and evaluation of KMC implementation. Findings from the EN-BIRTH study also supported this, showing that routine hospital KMC registers have the potential to track intervention coverage in KMC wards ( 19 ). Healthcare worker record was only slightly lower than the gold standard at the population level but did have low sensitivity (53%) and specificity (59%) at the individual level. Despite this, healthcare worker records showed reasonable point discrepancies with the gold standard at the individual level. To improve practice, incorporating more focused KMC-specific training or dedicated recording time may help enhance the accuracy of individual-level data. A study in Malawi found that healthcare workers tend to underestimate outcome measurements, and this practice increases over time ( 21 ). Another study reported evidence of over-reporting of newborn quality of care indicators compared to the gold standard ( 22 ). Other studies have also reported low accuracy in healthcare workers' documentation of medical records, especially for interventions rather than clinical outcomes ( 23 ). However, training healthcare workers in data management has been shown to improve both the completeness and accuracy data ( 24 ). This highlights the importance of training healthcare workers in KMC data monitoring as part of routine data collection to support the scaling up of the intervention. The high sensitivity (85%) of caregiver reports in this study may be due to social desirability bias, where caregivers tend to present a more favourable image ( 25 ). Similar findings were observed in a study validating KMC coverage through direct observation and exit interviews, which also reported high sensitivity but did not assess KMC duration ( 26 ). Generally, maternal self-reports have been noted to show higher sensitivity for events occurring immediately after childbirth, which aligns with our findings ( 27 ). However, caregiver reports in this study tended to overestimate the average daily KMC duration by about 1·7 hours. This implies that caregiver reports can be useful for tracking KMC coverage but should be interpreted with caution, particularly when assessing the duration of KMC. Healthcare systems should consider incorporating cross-verification mechanisms, such as routine checks or combining caregiver reports with healthcare worker records, to ensure more accurate reporting. About 67% of mother-baby pairs had a helper in the hospital who acted as a substitute KMC provider. These participants received an additional 1·9 to 2·0 hours of KMC daily, with an adult female relative being the main substitute KMC provider. Similarly, previous studies have identified grandmothers as key family support in hospitals ( 19 , 28 ). Research has shown that having a family member present helps maintain continuity of KMC and provides psychological support to mothers ( 29 , 30 ). The involvement of family members, particularly female relatives, is likely associated with longer KMC durations. However, there is no existing research that quantifies the additional KMC hours provided by family members apart from the findings of this study. Since longer KMC duration is linked to reduced neonatal mortality risk, further research is needed to identify strategies to increase KMC duration through family involvement. This study has strengths, including the provision of novel data on the validity of healthcare worker record and caregiver report for KMC duration measurement and the use of a time-stamped software application to improve data capture. However, our study also has some limitations. The frequency of independent observer measurements, at 2-hourly intervals, may have introduced a bias into the calculated agreement rates, as KMC duration may have varied between these observations. Continuous observation has not been considered feasible in other studies. Continuous video recording has been used previously in observational skin-to-skin studies; however, this has largely been for short period of observation, for example to examine the neonatal response to noxious stimuli like heel pricks procedures ( 31 ). Continuous video recording could be considered as an alternative reference standard for this study against which the commonly used methods in KMC studies could be validated. However, continuous video recording of KMC in an open ward care environment presents challenges around informed consent including limitations of anonymity, and the recording of non-research related activities of participants and non-participants receiving care in the mother-NICU ( 32 ). Another option could be an electronic device allowing continuous contact assessment. Future studies could investigate ways to implement healthcare worker records, and improve accuracy, such as training and standardisation of tools. These could be tested against alternative objective measures of KMC duration, such as innovative electronic position monitoring. Integration of KMC indicators into national health information systems is a feasible and essential step for improving the monitoring and evaluation of KMC programs. Given that healthcare worker records provide reasonably accurate estimates of KMC duration at the population level, policies should prioritize the routine collection and integration of this data. Additionally, encouraging active family involvement, particularly from female relatives, can significantly extend KMC duration, thereby reducing neonatal mortality. Healthcare facilities should adopt policies that facilitate family support in KMC, creating a comprehensive approach to improving infant health outcomes. Further research is needed to develop strategies that enhance KMC duration, particularly through the involvement of family members. Investigating ways to improve the accuracy of healthcare worker records, such as through training and standardization of data collection tools will be crucial. These methods could be tested against objective measures of KMC duration, including innovative technologies like electronic position monitoring, to validate and improve program monitoring and effectiveness. The healthcare worker record on average provides a reasonably accurate estimate of KMC duration at the population level, highlighting the feasibility of integrating KMC indicators into the national health information systems and could facilitate the monitoring and evaluation of KMC implementation with quality and lead to higher impact. Abbreviations CPAP Continuous positive airway pressure eCRF Electronic case report form eKMC iKMC Early kangaroo mother care (clinical trial) Immediate Kangaroo mother care (clinical trial) G kg Grams Kilograms GCP Good Clinical Practice HR Heart rate ICH International Council for Harmonization IRB Institutional Review Board IQR Interquartile range IV Intravenous KMC Kangaroo mother care LBW Low birthweight LMIC Low- and middle-income countries LSHTM London School of Hygiene & Tropical Medicine MRC Medical Research Council OMWaNA Operationalizing kangaroo Mother care among low birth-Weight Neonates in Africa (clinical trial) RCT Randomized controlled trial REC Research Ethics Committee SD Standard deviation SDG Sustainable Development Goal SSC Skin-to-skin care UCSF University of California San Francisco UVRI UPA UNICEF Uganda Virus Research Institute Uganda Paediatric Association United Nations Children’s Fund WHO NEST 360 o EN-BIRTH NSCU NMR U5MR World Health Organization Newborn Essential Solutions and Technologies (NEST 360°) Every Newborn-Birth Indicators Tracking in Hospitals Neonatal Special Care Unit Neonatal Mortality Rate Under-five Mortality Rate Declarations Acknowledgments: Most importantly, we thank the mothers, newborns, and families who participated in this study. We give huge appreciation to the neonatal unit nurses, doctors, and staff at Kawempe National Referral Hospital for their participation in the study but also their dedication throughout the study. We also appreciate the administration of Kawempe for allowing us space to conduct the study. Ethics approval and consent to participates: Informed consent was obtained from all participating mothers/caregivers before enrolment in the study. All data were collected and handled in accordance with strict confidentiality standards. Ethical approval was obtained from the Research Ethics Committees of the Uganda Virus Research Institute (GC/127/21/05/825), the London School of Hygiene and Tropical Medicine (#26394), and the University of California San Francisco (#21-33657). Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development (K23HD092611); Joint Global Health Trials scheme of the Department of Health and Social Care, Foreign, Commonwealth and Development Office, Medical Research Council, and Wellcome Trust (MR/S004971/1). Conflict of Interest: The authors declare no conflict of interest. Authors’ Contributions: VST conceptualised the study, wrote the protocol, analysed and interpreted the data, and wrote the first draft of the manuscript. CJT, MN, and MMM provided oversight of data collection. MMM secured funding for this sub-study and JEL secured funding for the overarching trial. JEL was the principal investigator of the OMWaNA trial and enabled the idea and the adaption of the time-stamped app from the EN BIRTH study. MMM, CJT, CO, and JEL reviewed the protocol, supervised the analysis, interpreted the data, and critically revised the manuscript. CO and IS contributed to the analysis. 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A validation study of maternal self reports of obstetrical complications: implications for health surveys. International Journal of Gynecology & Obstetrics. 1998;62(3):229-36. Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, et al. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021;39:101050. Smith ER, Bergelson I, Constantian S, Valsangkar B, Chan GJ. Barriers and enablers of health system adoption of kangaroo mother care: a systematic review of caregiver perspectives. BMC pediatrics. 2017;17(1):35. Bergh A-M, Davy K, Otai CD, Nalongo AK, Sengendo NH, Aliganyira P. Evaluation of kangaroo mother care services in Uganda. Washington D.C. and Kampala: Save the Children; 2012. Nimbalkar SM, Chaudhary NS, Gadhavi KV, Phatak A. Kangaroo mother care in reducing pain in preterm neonates on heel prick. The Indian journal of pediatrics. 2013;80:6-10. Scott M, Watermeyer J, Wessels TM. Video‐recording complex health interactions in a diverse setting: Ethical dilemmas, reflections and recommendations. Developing World Bioethics. 2020;20(1):16-26. Additional Declarations No competing interests reported. Supplementary Files Appendix1.docx Cite Share Download PDF Status: Published Journal Publication published 09 Apr, 2025 Read the published version in BMC Pediatrics → Version 1 posted Editorial decision: Revision requested 19 Dec, 2024 Reviews received at journal 24 Nov, 2024 Reviews received at journal 15 Nov, 2024 Reviewers agreed at journal 11 Nov, 2024 Reviewers agreed at journal 05 Nov, 2024 Reviewers invited by journal 05 Nov, 2024 Editor invited by journal 28 Oct, 2024 Editor assigned by journal 26 Oct, 2024 Submission checks completed at journal 26 Oct, 2024 First submitted to journal 22 Oct, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5313012","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":374485136,"identity":"fb634409-ec0b-46a6-8c09-5bc64f76fb36","order_by":0,"name":"Victor S. Tumukunde","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABIUlEQVRIiWNgGAWjYBACg8MINjMY88P5B3BqYWwA0hJwLZINhLQcQNdicICAFsl25ucPPu5hqDO4dsbYmHeHtZzxtbMPP/P8ssvjO36A8XHFL0wtzWyGjTOeMUgY3M4xTuY9k25sdjvdWJq3L7lY8kwCs+HZPixaeBibeQ5AtBzmbTucuO12Ghszbw9z4oYDCWySjT0YWviZ0bTUb54N1lKfuOH8A8JakoFaEgykgVp4fhxO3HADaEvDDwwtbMxshjNnHJCQnHk7rdhwblu64YzbacyScxuOJ8688bDZsLEBUwv/4QcfPhyw4ee7nbxZ4m2btTz/7DTGD2/+VCf2nU8++LDhD/aQhkQLMmBsA5MNUAZR4A8GYxSMglEwCkYuAACY626fe4WJ6AAAAABJRU5ErkJggg==","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Victor","middleName":"S.","lastName":"Tumukunde","suffix":""},{"id":374485137,"identity":"39850e92-0236-45b1-b214-6d5322e1f53f","order_by":1,"name":"Isaac Sekitoleko","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Isaac","middleName":"","lastName":"Sekitoleko","suffix":""},{"id":374485139,"identity":"eb8f6c80-aa54-4e24-88aa-a2491020d58e","order_by":2,"name":"Charles Opondo","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Charles","middleName":"","lastName":"Opondo","suffix":""},{"id":374485141,"identity":"baa13c10-50d1-47ab-89a3-812373b584f1","order_by":3,"name":"Moffat Nyirenda","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Moffat","middleName":"","lastName":"Nyirenda","suffix":""},{"id":374485143,"identity":"124b54ae-12c3-4208-adbe-9e95e4e1ae65","order_by":4,"name":"Cally J. Tann","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Cally","middleName":"J.","lastName":"Tann","suffix":""},{"id":374485146,"identity":"c16c7379-4729-4426-8851-8bc34ef3390b","order_by":5,"name":"Joy E. Lawn","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Joy","middleName":"E.","lastName":"Lawn","suffix":""},{"id":374485148,"identity":"b27737cf-bfca-4ee4-b294-ac7d0c7ae658","order_by":6,"name":"Melissa M. Medvedev","email":"","orcid":"","institution":"London School of Hygiene \u0026 Tropical Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Melissa","middleName":"M.","lastName":"Medvedev","suffix":""}],"badges":[],"createdAt":"2024-10-22 15:23:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5313012/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5313012/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12887-025-05629-1","type":"published","date":"2025-04-09T16:05:38+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":69081155,"identity":"4d232e2f-65bd-43a9-9072-57253df76553","added_by":"auto","created_at":"2024-11-15 11:57:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45330,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5313012/v1/9914232c24471865ad77eab5.png"},{"id":69081157,"identity":"f41a11fc-b642-4d41-89c0-a91c8478f230","added_by":"auto","created_at":"2024-11-15 11:57:03","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":370260,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5313012/v1/02ba91e2a11cfb1cecb571cf.png"},{"id":80558946,"identity":"441e7003-19d8-4eef-99eb-da7fbc88b554","added_by":"auto","created_at":"2025-04-14 16:17:16","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1250712,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5313012/v1/c4b4f496-28a0-4e0b-a79f-3939c5b2ceda.pdf"},{"id":69081154,"identity":"820619f1-e59e-4837-8134-ae4ec3a0838e","added_by":"auto","created_at":"2024-11-15 11:57:02","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":19552,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5313012/v1/489a9e22d93dfc50aaee0a65.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Kangaroo mother care among hospitalised neonates: evaluation of validity of duration measurement methods compared to observation linked to the OMWaNA trial in Uganda","fulltext":[{"header":"RESEARCH IN CONTEXT","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEvidence before this study:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eKangaroo mother care (KMC) improves survival of low birthweight neonates, with longer daily KMC duration linked to lower mortality risk. However, analyses of KMC duration remain unclear, partly due to the variability and unknown accuracy of measurement methods. Studies have traditionally relied on healthcare workers records or caregivers reports to assess KMC duration. We searched PubMed, without language restrictions, for published studies on validation of KMC duration measurement methods from Jan 1, 1990, to 21 November 2022, using the following search terms: \u0026ldquo;kangaroo mother care\u0026rdquo; [MeSH], or \u0026ldquo;care method, kangaroo mother\u0026rdquo; [MeSH], or \u0026ldquo;skin-to-skin contact\u0026rdquo; [MeSH], or \u0026ldquo;skin-to-skin care\u0026rdquo; [MeSH], and \u0026ldquo;monitoring,\u0026rdquo; or \u0026ldquo; measurement,\u0026rdquo; or \u0026ldquo;duration\u0026rdquo;. We found that the majority KMC studies relied on caregiver (54%) and healthcare worker records (31%) to measure KMC duration, with no reported validation of the methods.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAdded value of this study:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eThis study is the first published validation of the accuracy of KMC duration measurement methods, comparing healthcare worker records and caregiver reports against direct observation (considered the gold standard) using a time-stamped app. The findings demonstrate that, while healthcare worker records closely match the gold standard with a minimal mean difference of 0\u0026middot;2 hours lower, caregiver reports tend to overestimate KMC duration by an average of 1\u0026middot;7 hours. The study also highlights the benefit of having a helper (substitute KMC provider), with an additional 1\u0026middot;89 to 2\u0026middot;03 hours of KMC daily, depending on adjustments for maternal factors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eImplications of all the available evidence:\u003c/em\u003e\u003c/strong\u003e The reasonable accuracy of healthcare worker recording of KMC duration supports wider use, potentially in national health information systems, facilitating more reliable monitoring and evaluation of quality of KMC implementation. However, the lower agreement rates suggest the need for improved training and standardisation of reporting tools to enhance KMC duration measurements by healthcare workers. Caregiver reports are useful for tracking KMC coverage but should be interpreted cautiously when assessing KMC duration, especially in the absence of healthcare worker records. Our research also contributes more robust evidence to underscore the value of involving family members to increase the duration and effectiveness of this life-saving intervention.\u003c/p\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003eGlobally, 2\u0026middot;3\u0026nbsp;million neonatal deaths (first 28 days after birth) were estimated to occur in 2022(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Small vulnerable newborns (SVN), including those born preterm and small-for-gestational age, account for more than half of neonatal deaths, plus have an increased risk for post neonatal mortality and growth failure (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Mortality risk is highest in low- and middle-income countries (LMIC) due to gaps in coverage and quality of neonatal care (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Improving the care of small and sick neonates in hospitals is crucial to accelerating neonatal survival and meeting Sustainable Development Goals (SDGs) by 2030 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eKangaroo mother care (KMC) involves early and prolonged skin-to-skin contact (SSC), promotion of exclusive breastfeeding or breastmilk feeding, and follow-up after discharge. KMC is associated with decreased mortality, sepsis, hypothermia, hypoglycaemia, and length of hospital stay compared to conventional care among clinically stable neonates (\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). A meta-analysis of three trials of KMC initiated before stabilisation showed a 19% relative reduction in neonatal mortality at 28 days (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). KMC is recommended by the World Health Organisation (WHO) to be initiated as soon as possible after birth in all neonates weighing\u0026thinsp;\u0026lt;\u0026thinsp;2500 grams (g) (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eLonger durations of KMC are crucial for achieving positive health outcomes (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Research indicates that KMC only reduces mortality in stable neonates when provided for 20 hours or more daily, according to a Cochrane review (2016) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). A more recent review reported significant reduction in mortality at 28 days when the daily duration was at least 8 hours (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Conversely, another systematic review highlighted that some benefits of KMC are lost when the KMC duration is 2 hours or less (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). The OMWaNA trial in Uganda showed that neonates in the intervention group who received a median of 12\u0026ndash;24 hours of KMC per day had a lower risk of mortality at 7 days and 28 days compared to those receiving\u0026thinsp;\u0026lt;\u0026thinsp;12 hours per day (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Although the WHO recommends 8\u0026ndash;24 hours of KMC daily, this guideline is based on a systematic review that highlighted a lack of sufficient data on the optimal duration of KMC (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). The absence of reliable and validated methods to measure KMC duration complicates the interpretation of evidence from meta-analyses that combine studies with varying KMC measurement methods (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eBarriers to higher duration of KMC have been reported at both the health facility and community level. Studies have found that lack of beds and space, privacy issues, inadequate caregiver education, insufficient staff and monitoring devices, and difficulties motivating mothers to devote time were common barriers to KMC continuity in health facilities (\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Maternal factors, such as fatigue, depression, and postpartum pain, especially after a caesarean section, may reduce uptake and the time spent in the KMC position (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Women may find long hours of KMC challenging, impeding sleeping and eating, or after discharge, affecting time for household activities (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOur recent scoping review found 54 studies reporting on KMC duration. Of these, the majority of studies (29, 54%) used caregiver reports and a few (17, 31%) have used healthcare worker records to measure the duration of the intervention(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). However, evidence on the validity of these methods to accurately measure KMC duration is lacking. One previous study in Tanzania, Bangladesh and Nepal validated the coverage indicator of KMC and measured duration using a time-stamped app but did not validate the measurement of duration (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Although it is plausible that longer durations of KMC improve health outcomes amongst neonates, the evidence remains incomplete without more rigorously validated methods for measuring the duration of KMC.\u003c/p\u003e \u003cp\u003eThe aim of this study was to evaluate the validity of different methods for measuring KMC duration, compared to the gold standard of direct observation, among admitted newborns weighing\u0026thinsp;\u0026le;\u0026thinsp;2000g in Uganda.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cem\u003eStudy design, settings, and population\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis was an observational validation study embedded in the OMWaNA trial, a randomised, controlled trial examining the effect of KMC initiated prior to clinical stability on neonatal mortality, relative to standard care, in Uganda (20). The trial recruited between October 2019 and July 2022 in five hospitals across Uganda. Neonates recruited to the trial between October 2021 and July 2022 at the largest trial site, Kawempe National Referral Hospital in Kampala, were included in this KMC duration measurement validation sub-study (9). Participants included singleton, twin, or triplet (if triplet pregnancy resulted in demise of \u0026ge;1 fetus) neonates born weighing 700-2000g who were randomised to the intervention (KMC) arm of the trial, and their caregivers. Neonates with life-threatening instability (defined as oxygen saturation \u0026lt;88% while on oxygen support, and \u0026ge;1 of heart rate \u0026lt;100 or \u0026gt;200 beats/minute, respiratory rate \u0026lt;20 or \u0026gt;100 breaths/minute apnoea requiring bag-mask ventilation), jaundice requiring immediate treatment, active seizures, or major congenital malformation were excluded from the study.\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eStudy Procedure\u003c/em\u003e\u003cem\u003es\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKMC was initiated as soon as possible following recruitment into the trial. Neonates were placed onto the exposed chest of their caregiver skin-to-skin using a KMC wrap. Prior to placing neonates in the KMC position, a study nurse or medical officer demonstrated to caregivers how to perform KMC, breastfeed, and feed the baby expressed breastmilk. An independent observer (considered the gold standard) monitored neonates every 2 hours around the clock to record-time stamped data documenting if they were in the KMC position, as done in the EN-BIRTH KMC coverage indicator validation study (19). They also documented the KMC provider (mother or substitute provider) and reason for not performing KMC if it was not being practiced at the time of observation. Data were collected using a custom-built Android tablet-based software application adapted from the EN-BIRTH study (19). During routine nursing observations (every three hours), a study nurse (healthcare worker record) documented whether neonates were in the KMC position. Caregivers were provided with a \u0026ldquo;diary\u0026rdquo; in terms of paper chart and a pen, and a study nurse demonstrated how to record the start and end time of each episode of KMC (caregiver report). Illiterate caregivers were assisted to report by a literate caregiver participant. Results are reported in accordance with STROBE statement checklist for cross-sectional studies (appendix 1).\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eSample size\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size for the sub-study was 222 caregiver-baby pairs. This sample size provided 80% power to detect a difference of at least 0\u0026middot;96 hours in the mean daily duration of KMC, assuming an expected daily mean of 8 hours and a standard deviation (SD) of the difference in any pairwise comparison of 5\u0026middot;1 hours.\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eData analysis\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eParticipants social demographic characteristic where summarised using frequencies and proportions. We calculated healthcare worker-recorded and caregiver-reported duration of KMC and compared them with the independent observer\u0026rsquo;s documented KMC duration as means. To assess the accuracy of population level performance, we independently calculated and compared the gold standard observation with the healthcare worker record and caregiver-reported KMC duration for all mother-baby pairs using Bland-Altman plots. At individual level, point observations/records of KMC practice for the two methods were compared with the gold standard and validity \u0026ldquo;diagnostic test\u0026rdquo; methods were calculated using two-way tables, excluding missing pairwise data. Sensitivity, specificity, and positive predictive values were calculated for the two methods. A logistic regression model was applied to estimate the difference in KMC duration between the participants with a helper (substitute KMC provider) and those without. Stata version 18 (College Station, TX, USA) was used for all quantitative analyses.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 222 mother-baby pairs were enrolled, among which 219 initiated KMC. Three babies never started KMC due to worsening clinical conditions. About half of the newborns were male (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The mean gestational age at screening was 32 weeks (SD 2\u0026middot;5; 95% [CI] 26\u0026ndash;38) and the mean birthweight was 1\u0026middot;5kg (SD 0\u0026middot;3; 95% [CI] 0\u0026middot;8\u0026thinsp;\u0026minus;\u0026thinsp;2\u0026middot;0. Most women were aged 23\u0026ndash;34 years of age and were married or cohabiting (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCharacteristics of newborns and their mothers\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e% (n/N)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMothers\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10% (22/219)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e20\u0026ndash;34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e80.8% (177/219)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.3% (16/219)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMode of delivery\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNormal spontaneous vaginal delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e88.7% (196/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCaesarean delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.9% (22/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eForceps or vacuum-assisted vaginal delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.4% (3/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEmployment status, n (%)\u003c/b\u003e\u003csup\u003e^\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFormal employment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20.4% (45/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInformal employment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34.4% (76/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnpaid labour\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45.2% (100/221)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNeonates\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMale sex\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50.7% (111/219)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGestational age\u003c/b\u003e\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e \u003cb\u003eat screening (weeks), mean (SD)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e32 (2.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBirthweight (kg), mean (SD)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.5 (0.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBirthweight distribution (g), n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e700 to \u0026lt;\u0026thinsp;1000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.2% (7/220)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1000 to \u0026lt;\u0026thinsp;1500\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35% (77/220)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1500 to 2000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e61.8% (136/220)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003csup\u003e \u003cb\u003e*\u003c/b\u003e \u003c/sup\u003e \u003cem\u003eGestational age calculated by Ballard score.\u003c/em\u003e \u003csup\u003e\u003cem\u003e^\u003c/em\u003e\u003c/sup\u003e\u003cem\u003eFormal employment includes work for the government, the private sector, or non-governmental organisations. Informal employment includes work for private households, self-employment, and work on a farm or with livestock. Unpaid labour includes unemployment, student, home maker, and retired.\u003c/em\u003e\u003c/p\u003e \u003cp\u003e Caregivers reported 14,031 (77\u0026middot;5%) episodes in which the newborn was in the KMC position. Healthcare workers recorded 9,574 (53\u0026middot;1%) observations in which the newborn was in the KMC position. The independent observer reported 9,321 (51\u0026middot;1%) observations in which the newborn was in the KMC position. The KMC provider was a substitute caregiver (not the mother) in 2,455 (26\u0026middot;3%) observations by the independent observer in which the newborn was in the KMC position. The majority of substitute KMC providers were female relatives of the newborn, including auntie (51\u0026middot;6%) followed by grandmother (22\u0026middot;5%). Others included siblings (11\u0026middot;2%), fathers (11\u0026middot;1%), uncle (6\u0026middot;5%), and friend of the mother (0\u0026middot;7%).\u003c/p\u003e \u003cp\u003eFor 8,905 observations by the independent observer, newborns were not in KMC position. The reasons for not doing KMC were recorded for 8,250 (92\u0026middot;6%) observations. Caring for the newborn (including feeding, cleaning and medical care) was the main reason at 59\u0026middot;6% followed by caregiver self-care (bathing and having meals). Others included caregiver fatigue (8\u0026middot;1%), caregiver doing other cores (5\u0026middot;1%), newborn ill-health (4\u0026middot;0%) and care giver ill-health (1\u0026middot;5%).\u003c/p\u003e \u003cp\u003eThe mean cumulative KMC duration reported by independent observers was 67\u0026middot;8 hours (SD 64\u0026middot;6), with a mean daily duration of 8\u0026middot;4 hours (SD 3\u0026middot;5). Caregivers reported a mean cumulative KMC duration of 82\u0026middot;6 hours (SD 68\u0026middot;6) and a mean daily duration of 10\u0026middot;4 hours (SD 3\u0026middot;8), while healthcare workers recorded a mean cumulative KMC duration of 60\u0026middot;5 hours (SD 34\u0026middot;4) and a mean daily duration of 8\u0026middot;5 hours (SD 4\u0026middot;0) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e; Fig.\u0026nbsp;1).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCumulative and daily mean duration of KMC and validation test outcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"9\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCumulative duration of KMC (hours), mean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCumulative difference between methods and observer (hours), mean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDaily KMC duration (hours), mean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eDaily difference between methods and observer (hours), mean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003cp\u003e(95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003cp\u003e(95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ePositive predictive value (PPV)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003ePercent agreement\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eObserver (gold standard)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67\u0026middot;8 (64.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u0026middot;4 (3\u0026middot;5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHealthcare worker record\u003c/b\u003e\u003csup\u003e\u003cb\u003e\u0026dagger;\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e60\u0026middot;5 (34.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u0026middot;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u0026middot;5 (4\u0026middot;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u0026middot;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e52\u0026middot;6 (51\u0026middot;9\u0026ndash;53\u0026middot;3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e59\u0026middot;1 (58\u0026middot;3\u0026ndash;59\u0026middot;8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e57\u0026middot;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e55\u0026middot;7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCaregiver report\u003c/b\u003e\u003csup\u003e\u003cb\u003e^\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e82\u0026middot;6 (68.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-14\u0026middot;1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10\u0026middot;4 (3\u0026middot;8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-1\u0026middot;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e85\u0026middot;1 (84\u0026middot;5\u0026ndash;85\u0026middot;6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e30\u0026middot;5 (29\u0026middot;9\u0026ndash;31\u0026middot;2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e56\u0026middot;4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e58\u0026middot;6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eUsing the mean cumulative KMC duration to assess the level of agreement between the methods, the mean difference between independent observer and healthcare worker record was 9\u0026middot;5 (95% CI 3\u0026middot;5 to 15\u0026middot;5), implying that healthcare workers recorded KMC duration 9\u0026middot;5 hours shorter over the period of observation. The mean difference between independent observer and caregiver reports was \u0026minus;\u0026thinsp;14\u0026middot;1 (95% CI -17\u0026middot;6 to -10\u0026middot;6), meaning that caregivers reported KMC duration 14 hours longer over the period of observation.\u003c/p\u003e \u003cp\u003eUsing the mean daily KMC duration to assess the level of agreement between the methods, the mean difference between independent observer and healthcare worker records was 0\u0026middot;2 (95% CI -0\u0026middot;3 to 0\u0026middot;6; Fig.\u0026nbsp;2A). The mean difference between independent observer and caregiver report was \u0026minus;\u0026thinsp;1\u0026middot;7 (95% CI -2\u0026middot;1 to -1\u0026middot;3; Fig.\u0026nbsp;2B).\u003c/p\u003e \u003cp\u003eThe percentage agreement between independent observers and the two measurement methods were 55\u0026middot;7% for healthcare workers and 58\u0026middot;6% for caregivers (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Healthcare worker record had a sensitivity of 52\u0026middot;6% and a specificity of 59\u0026middot;1%, while caregiver report had a sensitivity of 85\u0026middot;1% and a specificity of 30\u0026middot;5%. The two methods had low positive predictive values of 57\u0026middot;6% and 56\u0026middot;4% for healthcare worker record and caregiver report, respectively.\u003c/p\u003e \u003cp\u003eAbout two-thirds (n\u0026thinsp;=\u0026thinsp;149, 67\u0026middot;1%) of participants had a helper during the hospital stay who acted as a substitute KMC provider in the place of the mother, accounting for 2,455 (26\u0026middot;3%) observations. Participants with a substitute KMC provider had a mean daily KMC duration of 9\u0026middot;8 hours (SE 0\u0026middot;3) compared to 7\u0026middot;9 hours (SE 0\u0026middot;4) for those who did not have a substitute KMC provider (mean difference 1\u0026middot;9 hours; 95% CI 0\u0026middot;9\u0026thinsp;\u0026minus;\u0026thinsp;2\u0026middot;8; p\u0026thinsp;\u0026lt;\u0026thinsp;0\u0026middot;001). After controlling for maternal age, parity, marital status, and employment category, the adjusted mean difference in daily KMC duration increased to 2\u0026middot;0 hours (95% CI 1\u0026middot;0\u0026ndash;3\u0026middot;0; p\u0026thinsp;\u0026lt;\u0026thinsp;0\u0026middot;001).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis is the first study to test the validity of healthcare worker record and caregiver report for KMC duration measurement, compared against independent observers as a \u0026ldquo;gold\u0026rdquo; standard using a time-stamped app. Our findings demonstrate that while healthcare worker records closely match the gold standard with a minimal mean difference of 0\u0026middot;2 hours lower, caregiver reports tend to overestimate KMC duration by an average of 1\u0026middot;7 hours. The study also highlights the significant impact of having a substitute KMC provider, with participants benefiting from an additional 1\u0026middot;9 to 2\u0026middot;0 hours of KMC daily.\u003c/p\u003e \u003cp\u003eOur results suggest that healthcare worker records can provide a relatively accurate estimate of KMC duration at the population level. These records could be integrated into national health information systems to support the monitoring and evaluation of KMC implementation. Findings from the EN-BIRTH study also supported this, showing that routine hospital KMC registers have the potential to track intervention coverage in KMC wards (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHealthcare worker record was only slightly lower than the gold standard at the population level but did have low sensitivity (53%) and specificity (59%) at the individual level. Despite this, healthcare worker records showed reasonable point discrepancies with the gold standard at the individual level. To improve practice, incorporating more focused KMC-specific training or dedicated recording time may help enhance the accuracy of individual-level data. A study in Malawi found that healthcare workers tend to underestimate outcome measurements, and this practice increases over time (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Another study reported evidence of over-reporting of newborn quality of care indicators compared to the gold standard (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Other studies have also reported low accuracy in healthcare workers' documentation of medical records, especially for interventions rather than clinical outcomes (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). However, training healthcare workers in data management has been shown to improve both the completeness and accuracy data (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). This highlights the importance of training healthcare workers in KMC data monitoring as part of routine data collection to support the scaling up of the intervention.\u003c/p\u003e \u003cp\u003eThe high sensitivity (85%) of caregiver reports in this study may be due to social desirability bias, where caregivers tend to present a more favourable image (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Similar findings were observed in a study validating KMC coverage through direct observation and exit interviews, which also reported high sensitivity but did not assess KMC duration (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Generally, maternal self-reports have been noted to show higher sensitivity for events occurring immediately after childbirth, which aligns with our findings (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). However, caregiver reports in this study tended to overestimate the average daily KMC duration by about 1\u0026middot;7 hours. This implies that caregiver reports can be useful for tracking KMC coverage but should be interpreted with caution, particularly when assessing the duration of KMC. Healthcare systems should consider incorporating cross-verification mechanisms, such as routine checks or combining caregiver reports with healthcare worker records, to ensure more accurate reporting.\u003c/p\u003e \u003cp\u003eAbout 67% of mother-baby pairs had a helper in the hospital who acted as a substitute KMC provider. These participants received an additional 1\u0026middot;9 to 2\u0026middot;0 hours of KMC daily, with an adult female relative being the main substitute KMC provider. Similarly, previous studies have identified grandmothers as key family support in hospitals (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). Research has shown that having a family member present helps maintain continuity of KMC and provides psychological support to mothers (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). The involvement of family members, particularly female relatives, is likely associated with longer KMC durations. However, there is no existing research that quantifies the additional KMC hours provided by family members apart from the findings of this study. Since longer KMC duration is linked to reduced neonatal mortality risk, further research is needed to identify strategies to increase KMC duration through family involvement.\u003c/p\u003e \u003cp\u003eThis study has strengths, including the provision of novel data on the validity of healthcare worker record and caregiver report for KMC duration measurement and the use of a time-stamped software application to improve data capture. However, our study also has some limitations. The frequency of independent observer measurements, at 2-hourly intervals, may have introduced a bias into the calculated agreement rates, as KMC duration may have varied between these observations. Continuous observation has not been considered feasible in other studies. Continuous video recording has been used previously in observational skin-to-skin studies; however, this has largely been for short period of observation, for example to examine the neonatal response to noxious stimuli like heel pricks procedures (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). Continuous video recording could be considered as an alternative reference standard for this study against which the commonly used methods in KMC studies could be validated. However, continuous video recording of KMC in an open ward care environment presents challenges around informed consent including limitations of anonymity, and the recording of non-research related activities of participants and non-participants receiving care in the mother-NICU (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). Another option could be an electronic device allowing continuous contact assessment. Future studies could investigate ways to implement healthcare worker records, and improve accuracy, such as training and standardisation of tools. These could be tested against alternative objective measures of KMC duration, such as innovative electronic position monitoring.\u003c/p\u003e \u003cp\u003eIntegration of KMC indicators into national health information systems is a feasible and essential step for improving the monitoring and evaluation of KMC programs. Given that healthcare worker records provide reasonably accurate estimates of KMC duration at the population level, policies should prioritize the routine collection and integration of this data. Additionally, encouraging active family involvement, particularly from female relatives, can significantly extend KMC duration, thereby reducing neonatal mortality. Healthcare facilities should adopt policies that facilitate family support in KMC, creating a comprehensive approach to improving infant health outcomes. Further research is needed to develop strategies that enhance KMC duration, particularly through the involvement of family members. Investigating ways to improve the accuracy of healthcare worker records, such as through training and standardization of data collection tools will be crucial. These methods could be tested against objective measures of KMC duration, including innovative technologies like electronic position monitoring, to validate and improve program monitoring and effectiveness.\u003c/p\u003e \u003cp\u003eThe healthcare worker record on average provides a reasonably accurate estimate of KMC duration at the population level, highlighting the feasibility of integrating KMC indicators into the national health information systems and could facilitate the monitoring and evaluation of KMC implementation with quality and lead to higher impact.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eCPAP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eContinuous positive airway pressure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eeCRF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eElectronic case report form\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eeKMC\u003c/p\u003e\n \u003cp\u003eiKMC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eEarly kangaroo mother care (clinical trial)\u003c/p\u003e\n \u003cp\u003eImmediate Kangaroo mother care (clinical trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eG\u003c/p\u003e\n \u003cp\u003ekg\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eGrams\u003c/p\u003e\n \u003cp\u003eKilograms\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eGCP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eGood Clinical Practice\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eHR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eHeart rate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eICH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eInternational Council for Harmonization\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eIRB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eInstitutional Review Board\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eIQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eInterquartile range\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eIntravenous\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eKMC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eKangaroo mother care\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eLBW\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eLow birthweight\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eLMIC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eLow- and middle-income countries\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eLSHTM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eLondon School of Hygiene \u0026amp; Tropical Medicine\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eMRC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eMedical Research Council\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eOMWaNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eOperationalizing kangaroo Mother care among low birth-Weight Neonates in Africa (clinical trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eRCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eRandomized controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eREC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eResearch Ethics Committee\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eSD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eStandard deviation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eSDG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eSustainable Development Goal\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eSSC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eSkin-to-skin care\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eUCSF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eUniversity of California San Francisco\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eUVRI\u003c/p\u003e\n \u003cp\u003eUPA\u003c/p\u003e\n \u003cp\u003eUNICEF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eUganda Virus Research Institute\u003c/p\u003e\n \u003cp\u003eUganda Paediatric Association\u003c/p\u003e\n \u003cp\u003eUnited Nations Children\u0026rsquo;s Fund\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.138%;\"\u003e\n \u003cp\u003eWHO\u003c/p\u003e\n \u003cp\u003eNEST 360\u003csup\u003eo\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003eEN-BIRTH\u003c/p\u003e\n \u003cp\u003eNSCU\u003c/p\u003e\n \u003cp\u003eNMR\u003c/p\u003e\n \u003cp\u003eU5MR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 81.862%;\"\u003e\n \u003cp\u003eWorld Health Organization\u003c/p\u003e\n \u003cp\u003eNewborn Essential Solutions and Technologies (NEST 360\u0026deg;)\u003c/p\u003e\n \u003cp\u003eEvery Newborn-Birth Indicators Tracking in Hospitals\u003c/p\u003e\n \u003cp\u003eNeonatal Special Care Unit\u003c/p\u003e\n \u003cp\u003eNeonatal Mortality Rate\u003c/p\u003e\n \u003cp\u003eUnder-five Mortality Rate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eMost importantly, we thank the mothers, newborns, and families who participated in this study. We give huge appreciation to the neonatal unit nurses, doctors, and staff at Kawempe National Referral Hospital for their participation in the study but also their dedication throughout the study. We also appreciate the administration of Kawempe for allowing us space to conduct the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participates:\u0026nbsp;\u003c/strong\u003eInformed consent was obtained from all participating mothers/caregivers before enrolment in the study. All data were collected and handled in accordance with strict confidentiality standards. Ethical approval was obtained from the Research Ethics Committees of the Uganda Virus Research Institute (GC/127/21/05/825), the London School of Hygiene and Tropical Medicine (#26394), and the University of California San Francisco (#21-33657).\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eEunice Kennedy Shriver National Institute of Child Health \u0026amp; Human Development (K23HD092611); Joint Global Health Trials scheme of the Department of Health and Social Care, Foreign, Commonwealth and Development Office, Medical Research Council, and Wellcome Trust (MR/S004971/1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest:\u0026nbsp;\u003c/strong\u003eThe authors declare no conflict of interest. \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; Contributions:\u0026nbsp;\u003c/strong\u003eVST conceptualised the study, wrote the protocol, analysed and interpreted the data, and wrote the first draft of the manuscript. CJT, MN, and MMM provided oversight of data collection. MMM secured funding for this sub-study and JEL secured funding for the overarching trial. JEL was the principal investigator of the OMWaNA trial and enabled the idea and the adaption of the time-stamped app from the EN BIRTH study. MMM, CJT, CO, and JEL reviewed the protocol, supervised the analysis, interpreted the data, and critically revised the manuscript. CO and IS contributed to the analysis. All authors reviewed the manuscript and approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e\u0026nbsp;The manuscript does not contain any individual person\u0026rsquo;s data that requires consent for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials: \u003c/strong\u003eThe data supporting the results reported in this manuscript is stored on the Medical Research Council (MRC) and London School of Hygien and Tropical Medicine (LSHTM) Uganda Research Unit secure servers. This data is availaed on request to the data manager through the corresponding author.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eUNICEF. UN Inter-agency Group for Child Mortality Estimation. 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The need for pragmatic clinical trials in low and middle income settings\u0026ndash;taking essential neonatal interventions delivered as part of inpatient care as an illustrative example. BMC medicine. 2016;14(1):5.\u003c/li\u003e\n\u003cli\u003eConde‐Agudelo A, D\u0026iacute;az‐Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database of Systematic Reviews. 2016(8).\u003c/li\u003e\n\u003cli\u003eBoundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, et al. Kangaroo mother care and neonatal outcomes: a meta-analysis. Pediatrics. 2016;137(1):e20152238.\u003c/li\u003e\n\u003cli\u003eOrganization WH. Kangaroo mother care: implementation strategy for scale-up adaptable to different country contexts. 2023.\u003c/li\u003e\n\u003cli\u003eTumukunde V, Medvedev MM, Tann CJ, Mambule I, Pitt C, Opondo C, et al. Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation. The Lancet. 2024;403(10443):2520-32.\u003c/li\u003e\n\u003cli\u003eWHO. Recommendations for care of the preterm or low birth weight infant. Geneva: World Health Organization. 2022.\u003c/li\u003e\n\u003cli\u003eZengin H, Suzan OK, Hur G, Kolukısa T, Eroglu A, Cinar N. The effects of kangaroo mother care on physiological parameters of premature neonates in neonatal intensive care unit: A systematic review. Journal of Pediatric Nursing. 2023.\u003c/li\u003e\n\u003cli\u003eSivanandan S, Sankar MJ. Kangaroo mother care for preterm or low birth weight infants: a systematic review and meta-analysis. BMJ Global Health. 2023;8(6):e010728.\u003c/li\u003e\n\u003cli\u003eCharpak N, Montealegre‐Pomar A, Bohorquez A. Systematic review and meta‐analysis suggest that the duration of Kangaroo mother care has a direct impact on neonatal growth. Acta Paediatrica. 2021;110(1):45-59.\u003c/li\u003e\n\u003cli\u003eChisenga JZ, Chalanda M, Ngwale M. Kangaroo Mother Care: A review of mothers\u0026apos;\u0026apos;experiences at Bwaila hospital and Zomba Central hospital (Malawi). Midwifery. 2015;31(2):305-15.\u003c/li\u003e\n\u003cli\u003eFerrarello D, Hatfield L. Barriers to skin-to-skin care during the postpartum stay. MCN: The American Journal of Maternal/Child Nursing. 2014;39(1):56-61.\u003c/li\u003e\n\u003cli\u003eMorgan MC, Nambuya H, Waiswa P, Tann C, Elbourne D, Seeley J, et al. Kangaroo mother care for clinically unstable neonates weighing\u0026le; 2000 g: Is it feasible at a hospital in Uganda? Journal of global health. 2018;8(1).\u003c/li\u003e\n\u003cli\u003eChan GJ, Labar AS, Wall S, Atun R. Kangaroo mother care: a systematic review of barriers and enablers. Bulletin of the World Health Organization. 2016;94(2):130.\u003c/li\u003e\n\u003cli\u003eTumukunde VS LE, Medvedev MM, Nyirenda M, Tann CJ, Lawn JE. Measuring duration of Kangaroo Mother Care for low birthweight neonates: A scoping review BMJ Open (in press). 2024.\u003c/li\u003e\n\u003cli\u003eSalim N, Shabani J, Peven K, Rahman QS, Kc A, Shamba D, et al. Kangaroo mother care: EN-BIRTH multi-country validation study. BMC Pregnancy \u0026amp; Childbirth. 2021;21(Suppl 1):231.\u003c/li\u003e\n\u003cli\u003eMedvedev MM, Tumukunde V, Mambule I, Tann CJ, Waiswa P, Canter RR, et al. Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda. Trials. 2020;21(1):126.\u003c/li\u003e\n\u003cli\u003eAmouzou A, Banda B, Kachaka W, Joos O, Kanyuka M, Hill K, Bryce J. Monitoring child mortality through community health worker reporting of births and deaths in Malawi: validation against a household mortality survey. PLoS One. 2014;9(2):e88939.\u003c/li\u003e\n\u003cli\u003eBhattacharya AA, Allen E, Umar N, Usman AU, Felix H, Audu A, et al. Monitoring childbirth care in primary health facilities: a validity study in Gombe State, northeastern Nigeria. Journal of global health. 2019;9(2).\u003c/li\u003e\n\u003cli\u003ePaans W, Sermeus W, Nieweg RM, Van Der Schans CP. Prevalence of accurate nursing documentation in patient records. Journal of advanced nursing. 2010;66(11):2481-9.\u003c/li\u003e\n\u003cli\u003eNwankwo B, Sambo MN. Can training of health care workers improve data management practice in health management information systems: a case study of primary health care facilities in Kaduna State, Nigeria. Pan African Medical Journal. 2018;30(1).\u003c/li\u003e\n\u003cli\u003eGrimm P. Social desirability bias. Wiley international encyclopedia of marketing. 2010.\u003c/li\u003e\n\u003cli\u003eDay LT, Rahman QS-u, Rahman AE, Salim N, Ashish K, Ruysen H, et al. Assessment of the validity of the measurement of newborn and maternal health-care coverage in hospitals (EN-BIRTH): an observational study. The Lancet Global Health. 2021;9(3):e267-e79.\u003c/li\u003e\n\u003cli\u003eSeoane G, Castrillo M, O\u0026apos;Rourke K. A validation study of maternal self reports of obstetrical complications: implications for health surveys. International Journal of Gynecology \u0026amp; Obstetrics. 1998;62(3):229-36.\u003c/li\u003e\n\u003cli\u003eBrotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, et al. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates \u0026lt;2000 grams: A randomised controlled trial. EClinicalMedicine. 2021;39:101050.\u003c/li\u003e\n\u003cli\u003eSmith ER, Bergelson I, Constantian S, Valsangkar B, Chan GJ. Barriers and enablers of health system adoption of kangaroo mother care: a systematic review of caregiver perspectives. BMC pediatrics. 2017;17(1):35.\u003c/li\u003e\n\u003cli\u003eBergh A-M, Davy K, Otai CD, Nalongo AK, Sengendo NH, Aliganyira P. Evaluation of kangaroo mother care services in Uganda. Washington D.C. and Kampala: Save the Children; 2012.\u003c/li\u003e\n\u003cli\u003eNimbalkar SM, Chaudhary NS, Gadhavi KV, Phatak A. Kangaroo mother care in reducing pain in preterm neonates on heel prick. The Indian journal of pediatrics. 2013;80:6-10.\u003c/li\u003e\n\u003cli\u003eScott M, Watermeyer J, Wessels TM. Video‐recording complex health interactions in a diverse setting: Ethical dilemmas, reflections and recommendations. Developing World Bioethics. 2020;20(1):16-26.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Kangaroo mother care, low-birth-weight, neonate, prematurity, Validation","lastPublishedDoi":"10.21203/rs.3.rs-5313012/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5313012/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eStudies evaluating the impact of kangaroo mother care (KMC) on neonatal mortality and morbidity often rely on healthcare worker records or caregiver reports to measure intervention duration. However, the accuracy of these methods remains uncertain. We examined the validity of different methods of KMC duration measurement amongst neonates\u0026thinsp;\u0026le;\u0026thinsp;2000g in Uganda.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis observational study was embedded within the OMWaNA trial, which examined the impact of KMC on neonatal mortality before clinical stability. An independent observer (considered the gold standard) monitored neonates every 2 hours to confirm KMC position, using an Android tablet-based application adapted from the EN-BIRTH study. The gold standard was compared to routine healthcare workers charting and caregiver diary reports of KMC.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAmong 222 caregiver-newborn pairs, 219 initiated KMC. The mean daily KMC duration recorded by the gold standard was 8\u0026middot;4 hours (SD 3\u0026middot;5). Healthcare workers reported an average of 8\u0026middot;5 hours (SD 4\u0026middot;0), while caregivers reported 10\u0026middot;4 hours (SD 3\u0026middot;8). The mean difference was 0\u0026middot;2 hours less for healthcare workers (95% CI -0\u0026middot;3 to 0\u0026middot;6) and 1\u0026middot;7 hours more for caregivers (-2\u0026middot;1 to -1\u0026middot;3) compared to the gold standard. Agreement rates for individual KMC episodes were 55\u0026middot;2% (95% CI 54\u0026middot;4\u0026ndash;55\u0026middot;9) for healthcare workers and 58\u0026middot;2% (57\u0026middot;2\u0026ndash;59\u0026middot;0) for caregivers. Participants with a helper (substitute KMC provider) had longer daily duration compared to those without (mean difference 1\u0026middot;89 hours [0\u0026middot;89\u0026thinsp;\u0026minus;\u0026thinsp;2\u0026middot;84]; p\u0026thinsp;\u0026lt;\u0026thinsp;0\u0026middot;001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eHealthcare worker records provide a reasonably accurate estimate of KMC duration at the population level, supporting the integration of KMC indicators into national health information systems to facilitate monitoring and evaluation. Presence of a helper increases KMC duration, underscoring the need for research to identify strategies to increase family involvement.\u003c/p\u003e","manuscriptTitle":"Kangaroo mother care among hospitalised neonates: evaluation of validity of duration measurement methods compared to observation linked to the OMWaNA trial in Uganda","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-15 11:56:57","doi":"10.21203/rs.3.rs-5313012/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-12-19T12:29:59+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-24T18:10:52+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-15T12:24:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"178837902952517733756429264511152740013","date":"2024-11-11T06:51:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"88056565193296551047898465025504195065","date":"2024-11-05T23:16:50+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-11-05T16:51:45+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-10-28T20:03:47+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-10-26T04:15:17+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-10-26T04:13:59+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pediatrics","date":"2024-10-22T15:09:37+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f134f9aa-774c-4c6f-a239-f2592dfbe432","owner":[],"postedDate":"November 15th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-04-14T16:13:22+00:00","versionOfRecord":{"articleIdentity":"rs-5313012","link":"https://doi.org/10.1186/s12887-025-05629-1","journal":{"identity":"bmc-pediatrics","isVorOnly":false,"title":"BMC Pediatrics"},"publishedOn":"2025-04-09 16:05:38","publishedOnDateReadable":"April 9th, 2025"},"versionCreatedAt":"2024-11-15 11:56:57","video":"","vorDoi":"10.1186/s12887-025-05629-1","vorDoiUrl":"https://doi.org/10.1186/s12887-025-05629-1","workflowStages":[]},"version":"v1","identity":"rs-5313012","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5313012","identity":"rs-5313012","version":["v1"]},"buildId":"cBFmMYwuxLRRLfASyISRj","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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