Quantitative Assessment of Comfort and Physiological Responses in Neonates and Infants During Transport: A Pilot Study

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The American Academy of Pediatrics and the World Health Organization have issued recommendations to limit noise levels for newborns, but no specific regulations currently address vibration exposure. Study Objective : To quantitatively assess comfort and physiological stability in neonates and infants during a pram transport. Materials and Methods: Healthy neonates and infants (<6 months old) were enrolled for a 15-min walk using a commercially available pram over different surfaces. Vibrations were recorded using accelerometers, while physiological parameters were monitored with a neonatal SpO₂ sensor. Comfort and physiological scores were assessed using the Transport Risk Index of Physiologic Stability score and Comfort Neo Scale. Results : Eighteen subjects (median age: 93 days, IQR [59, 158]; median weight: 5.5 kg (IQR [5, 7.5]) were included. Median vibration total value ranged from 1.10 to 2.71 m/s², with the highest values recorded on gravel surfaces. Higher vibration total values correlated with greater agitation scores (r = .487, p = .008). Increased heart rate was associated with greater alertness (r = .550, p = .029) and body movement (r = .554, p = .035). Lower oxygen saturation correlated with increased agitation (r = -.234, p = .037) and facial tension (r = -.380, p > .001). Conclusions: Mechanical vibrations during pram transport were associated with behavioral changes in neonates and infants, with higher vibration exposure correlating with greater agitation scores. These findings highlight the need for further research to define safe vibration exposure thresholds, particularly for hospital neonatal transport. neonatal comfort neonatal transport safety threshold mechanical vibration Figures Figure 1 Figure 2 Figure 3 What’s Known on This Subject Neonatal and infant transport, both in and out of hospitals, causes significant stress due to mechanical vibrations. However, no specific regulations address vibration exposure, and its impact on overall physiological regulation remains poorly understood. What This Study Adds: This study included healthy newborns and infants instead of manikins, allowing a direct assessment of vital parameters and comfort in response to vibration exposure. Our findings demonstrate that different vibration levels may impact both behavioral and physiological parameters in this population. Introduction Neonatal well-being has become an increasingly central focus in modern neonatology, particularly for preterm infants, whose vulnerability demands greater attention to care conditions. In this context, the prevention and early recognition of pain, along with the minimization of environmental stressors such as noises and mechanical vibrations, are crucial to protecting neonatal health 1,2 . Neonatologists are increasingly prioritizing these goals, supported by recommendations from both the American Academy of Pediatrics and the World Health Organization, which advise that noise levels for newborns should not exceed 45 dB per hour 3–5 . However, while guidelines for noise are well-defined, specific regulations for vibrations remain absent. Existing standards, designed primarily for adult occupational health, fail to address the unique vulnerabilities of neonates. Neonatal transport represents a significant source of stress, particularly due to exposure to mechanical vibrations 6–8 . Studies have shown an association between transport and increased mortality and morbidity, especially in preterm and low-birth-weight infants, attributed in part to their immature central nervous system and the physiological instability characteristic of this developmental stage 9,10 . However, the specific impact of vibrations overall physiological regulation remains poorly understood. Understanding the phenomenon of resonance is crucial in this context. Resonance occurs when external vibrations align with the natural frequency of a tissue or organ, amplifying the applied forces and potentially causing harm 11,12 . While the resonance frequencies of adult tissues and organs are well-studied, no equivalent reference values exist for neonates 13 . This lack of data underscores the need for research aimed at identifying harmful vibration intensities and establishing safety thresholds to protect this vulnerable population. Although current research has shed light on vibration exposure during air and ambulance transport 14–16 , safety thresholds for neonates remain undefined. It is known that tone and posture in newborns and infants differ significantly from those of adults because of the developmental and neurological immaturity present in early life: in the first six months of life individuals do not have complete head control and exhibit a physiological flexion posture 17 . The safety and the health of newborns are typically evaluated using specific comfort and risk assessment scores. The TRIPS (Transport Risk Index of Physiologic Stability) score is a clinical tool used to assess the risk of physiologic instability in neonates during transport, whether intra-hospital or between healthcare facilities. This score helps predict outcomes by evaluating a neonate's condition at the time of transport, with higher TRIPS scores indicating greater physiologic instability and a higher risk of adverse outcomes 18 . Additionally, several validated pain scales have been developed specifically for newborns, considering their unique developmental and physiological characteristics, which require specialized tools to assess pain. These scales primarily rely on behavioral and physiological indicators, as newborns cannot verbally express pain. Among these, the Comfort Neo Scale (CNS) is a particularly valuable tool for assessing pain and discomfort in neonates, offering an objective method to measure their comfort and distress levels 19 . This study aims to assess if physiological data are descriptive of behavioural data and if vibration exposure levels during neonatal transport in a pram affect neonatal well-being, focusing on physiological stability and comfort. Materials and Methods This study was conducted at the University Hospital of Padua between June and October 2024. The study, titled “ Quantification of Child Well-being ” (ID 22835, URC Code AOP3233), was coordinated by the Department of Neurosciences at the University of Padua in collaboration with Padua Neonatal Intensive Care Unit (NICU). Ethical approval was obtained from the Territorial Ethics Committee (5934/AO/24) on May 9, 2024. Participants The study included term neonates and infants, aged 0 to 6 months, with normal perinatal conditions and no active diseases. Written informed consent was obtained from both parents. Preterm neonates and those with acute or chronic medical conditions were excluded. Prior to participation, all subjects underwent a standardized pediatric examination, including vital parameters assessment. Neurological evaluations were conducted using the Hammersmith Neonatal Neurological Examination (HNNE) for neonates and the Hammersmith Infant Neurological Examination (HINE) for infants 30,31 , focusing on posture and axial and appendicular tone. Transport Test The transport test involved the use of a modern pram 20 over asphalt, porphyry and gravel, while the parent pushed the pram in a forward direction (straight line). No ascending or descending paths were considered. The total transport duration was approximately 15 minutes. Data collection was performed in an outdoor setting to simulate real-life conditions. Vibration Measurement Vibrations during transport were recorded using the Wave Plus system by Cometa (Milan), which simultaneously captures acceleration (g) and angular velocity (°/s) data from inertial measurement units (IMUs) with a sampling frequency of 284 Hz (operating temperature range: [0-50]◦C , acceleration measurement range: ± 16 g, dimension: 32x17x12 mm, weight: 10-14 g). Sensors were positioned on the infant’s body (trunk) and on the ankle of the mother pushing the pram (Fig. 1). Data visualization and processing were performed in MATLAB. Physiological Parameters and Behavioral Assessment Physiological parameters (heart rate, blood pressure, oxygen saturation, respiratory rate, and body temperature) were recorded at the beginning and end of transport. Continuous monitoring of heart rate and oxygen saturation was performed using a neonatal SpO2 sensor (Radical-7 Pulse CO-Oximeter, Masimo). The heart rate during transport was also extracted from the data provided by a sensor placed on the child's chest. The reference range for vital parameters was based on values previously published, stratified by age 21 . The Transport Risk Index of Physiologic Stability (TRIPS) 18,22–24 score was used to assess the physiological stability of neonates before and after transport. Neonatal comfort was evaluated at five distinct points during the test using the Comfort Neo Scale (CNS) 25,26 , which assesses seven behavioral parameters. A TRIPS score below 10 indicates no significant illness severity, while CNS values less than or equal to 14 were interpreted as indicating no signs of discomfort. For each transport, a video was recorded, allowing for multiple evaluations of the same participant by different clinicians to ensure reliability. Data Analysis Descriptive statistical analyses were conducted on clinical data. Vibration signal analysis was performed using MATLAB 2024a 27 , computing the vibration total value (VTV) on the infants’ trunk as the square root of the sum of the root mean square (rms) values on the detrended acceleration data along the x axis (along the direction of movement), y axis (parallel to the ground and perpendicular to the direction of movement) and z axis (parallel to the gravity) measured in m/s² for at least 30 seconds on each terrain segment. Raw data were detrended to remove time-varying drifts and the gravity components. The frequency weighting proposed in ISO 2631-1 was not applied because sensors were directly on the person and not on the contact surface between the person and the means of transport. Results were visualized using boxplots to assess data distribution and variability. Regression analyses were performed using R 4.1 to investigate the association between physiological and behavioral data, controlling for possible cofounders (i.e. age, weight). significance was set at p > 0.05. Statistically significant results are indicated by an asterisk. Positive values indicate that both variables increase or decrease together. Negative values indicate that the variables move in opposite directions. Results A total of 18 neonates and infants who met the eligibility criteria were included in the study. The average age was 102 days (range: 18-179), with a median of 93 days. The average weight was 5.87 kg (range: 2.8-8.8), with a median of 5.5 kg. At the initial medical examination, all subjects had a regular clinical examination and vital parameters within normal ranges. Muscle tone and posture, assessed using the Hammersmith Neurological Examination according to the subject's age, were appropriate for their developmental stage. The average comfort score, evaluated using the CNS, was 14 (range: 6-20), with a median of 15 at baseline. Physiological stability, assessed using the TRIPS score, recorded an average of 1.4 (range: 0-8), with a median of 1 at the beginning of the transport. Vibration Transmission The vibration patterns in the time domain transmitted to the pram-neonate system were similar across the different samples. A higher intensity of vibrations was observed on the gravel section compared to the other segments of the path. Median vibration intensity, measured as vibration total value (VTV), ranged, on average, from 1.10 to 2.71 m/s², with the highest values recorded on gravel surfaces (Fig. 2, fourth row). Vital Parameters Evaluation Heart rate analysis revealed no significant variations over time, remaining within normal ranges throughout the transport. On uneven surfaces, a slight increase in the median heart rate was observed (Fig. 2, first row). Continuous monitoring of SpO 2 levels showed stability with no significant variations during transport, remaining within normal ranges. Outlier values were associated with episodes of infant crying, where temporary loss of the oximeter signal may have influenced the data (Fig. 2, third row). Physiological Stability Evaluation No significant differences in physiological stability, assessed using the TRIPS score, were observed before and after transport. At the end of the transport, the TRIPS score showed a mean of 1.5 (range: 0-6), with a median of 1, unchanged from baseline (Fig. 3). Comfort Evaluation Comfort, measured using the CNS, showed considerable variability between subjects. The median CNS score was lower on the porphyry segment compared to others (Fig. 3). Notably there was a slight reduction in alertness and mobility on the porphyry and gravel segments. Relationship between vibrations, comfort and physiological parameters adjusting for weight and age We found that all parameters were correlated with the weight and age of the child [|r| = .069 - .438]. This suggests us to consider age and weight as cofounders (Fig.2 and Fig. 3). Adjusting data for weight and age we notice that physiological parameters (VTV, bpm and SpO 2 ) are related to some behavioural parameters: higher VTV values were associated with greater agitation scores (r = .487, p = .008); higher bpm values were associated with greater alertness (r = .550, p = .029) and body movement scores (r = .554, p = .035); lower oxygen saturation values were associated with greater agitation (r = -.234, p = .037) and facial tension scores (r = -.380, p > .001). The results also suggest a tendency for the state of alertness to decrease as the perceived vibrations increase (Table 1). Table 1 Association between physiological and behavioral data, adjusted for possible cofounders. Asterisks indicate significant associations (p < .05). CNS score CNS total CNS agitation CNS alertness CNS crying CNS facial tension CNS body movement CNS tone VTV 1.499 (p = .058) .487* (p = .008) .215 (p = .090) .220 (p = .173) .240 (p = .151) .211 (p = .270) .024 (p = .674) bpm 2.301 (p = .060) .134 (p = .430) .550* (p = .029) .235 (p = .297) .380 (p = .077) .554* (p = .035) .327 (p = .080) SpO 2 .683 (p = .585) -.234* (p = .037) .479 (p = .197) .070 (p = .707) -.380* (p < .001) -.039 (p = .834) .046 (p = .799) Discussion This pilot study analyzed the impact of vibrations during "recreational" transportation in a commercial pram across different terrains on vital parameters and comfort in 18 healthy subjects aged 0-6 months. To our knowledge, this is the first study which analyzed comfort and vibration transmissions during a transport with a commercial pram, which is typically considered the safest and the most comfortable transport means for healthy newborns and infants. Our findings demonstrate that vibrations can influence both comfort and vital parameters, even in a recreational setting, although all observed changes remain within safe ranges. We found that all parameters are correlated with the weight and age of the child: the smaller the infants, the more susceptible they are to the effects of vibrations. As expected, we observed that physiological parameters such as vibration total value recorded at the infants’ trunk (VTV), heart rate (bpm) and oxygen saturation (SpO₂) were significantly associated with behavioral responses: VTV were positively correlated with agitation scores; higher bpm values were associated with greater alertness and increased body movement scores; lower oxygen saturation values correlated with increased agitation and facial tension scores. Furthermore, our results suggest a trend where higher perceived vibration levels are associated with a decrease in alertness, a phenomenon previously documented in adult studies 28 . This highlights the potential impact of prolonged vibration exposure on neonatal behavioral states. Vibration intensity (VTV) ranged, on average, from 1.10 to 2.71 m/s², depending on terrain type, with the highest values observed on gravel. Comparisons with prior studies on neonatal transport in ambulance and aircraft show that whole-body vibrations in those settings range from 0.04 to 5.6 m/s², with higher peaks occurring in air transport 14,15 . As neonatal-specific vibration assessment methods are unavailable, using workplace standards for adults it seems that the recorded accelerations exceed the "comfortable" thresholds for adults (ISO 2631-1:1997) 29 . Despite these findings, changes in vital parameters, physiological stability (TRIPS score), or comfort (CNS) observed during transport remain in safe ranges. This outcome was expected given the study’s short transport duration, the infants’ healthy status, and the cushioning effect of the pram. Interestingly, increased exposure to vibrations was associated with a higher CNS score, suggesting a potential link between vibration intensity and infant discomfort. While our study provides an initial understanding of these interactions, further research is needed to determine whether longer exposure durations or higher vibration levels could have more pronounced physiological or behavioral effects. One of the main strengths of this study is the use of newborns and infants instead of manikins, allowing for a direct assessment of vital parameters and comfort in response to vibration exposure. Previous studies that included real infants did not integrate clinical data with vibration and sound exposure measurements, often relying on adult reference standards 15,16 . However, several limitations of our study should be considered. First, the lack of standardized methods for assessing neonatal exposure to vibrations makes direct comparisons with other studies challenging. Additionally, comfort evaluation is inherently subjective and may be influenced by environmental factors such as temperature, lighting, and noise, introducing potential bias in the results. Another challenge is the technical limitations of monitoring devices, as signal loss—particularly during episodes of infant crying—may have affected the accuracy of some physiological measurements. To address these issues, future research should focus on refining measurement techniques and developing neonatal-specific assessment criteria. Looking ahead, further studies should explore longer transport durations to assess potential cumulative effects of vibration exposure on neonatal physiology and behavior. Investigations focusing on intra- and inter-hospital transport—where vibration levels are typically higher—are particularly needed. Additionally, advancements in vibration-damping technologies and more precise neonatal monitoring tools will be crucial for improving the safety and comfort of transported infants. These efforts will contribute to the development of evidence-based safety guidelines for neonatal transport. Conclusions In this pilot study, we applied a method to quantitatively assess comfort and the effects of vibration during transport in newborns and infants. Our findings demonstrate that different vibration levels may impact both behavioral and physiological parameters in this population. Applying this protocol to real-world transport scenarios, including intra- and inter-hospital transfers, could help establish safer vibration thresholds for neonates and infants. Defining specific safety standards for neonatal transport remains crucial. Future research should focus on refining measurement techniques, addressing current methodological limitations, and investigating a broader range of transport conditions. These efforts will be essential in developing evidence-based guidelines that enhance neonatal transport practices, ensuring both safety and long-term well-being for this vulnerable population. Abbreviations CNS Comfort Neo Scale IMUs Inertial measurement units NICU Neonatal Intensive Care Unit RMS Root mean square TRIPS Transport Risk Index of Physiologic Stability VTV Vibration Total Value Declarations Conflict of Interest Disclosures: Ivan Tomasi is a legal representative of L'Inglesina Baby SpA. The authors declare no other potential conflicts of interest relevant to this article. Funding/Support: This study was supported by "Ministero delle Imprese e del Made in Italy" (D.M. MISE 31/12/2021 – Accordi per l’innovazione - Id: 10210 - MISE 127 - DESIGN FOR BABY WELLNESS). Maria Rubega and Edoardo Passarotto are supported by the European Union- Next Generation EU, Mission 4 Component 1 (CUP C53D23006170006). Contributors Statement Dr Anna Trivillin and Dr Maria Elena Cavicchiolo collected the data and wrote the manuscript. Dr Maria Rubega collected the data, conceived the experiment and coordinated the data collection and analysis. Dr Paola Contessa collected the data and conceived the experiment. Dr Edoardo Passarotto performed the statistical analysis. Prof Alberto Trevisani supervised the experiment and the analysis. Eng. Ivan Tomasi supervised the experiment and the analysis. Prof Stefano Masiero obtained the Ethical Committee clearance and conceived the experiment. Prof Eugenio Baraldi and Dr Giovanna Verlato commented and approved all the drafts of the manuscript. All the authors read and approved the final version of the manuscript. References Grunau RE (2013) Neonatal Pain in Very Preterm Infants: Long-Term Effects on Brain, Neurodevelopment and Pain Reactivity. Rambam Maimonides Med J. ;4(4) Giordano V (2023) Pain and neurodevelopmental outcomes of infants born very preterm. Dev Med Child Neurol White RD Recommended standards for newborn ICU design, 9th edition. J Perinatol . Published online 2020 Altimier L, Barton SA, Bender J et al (2023) Recommended standards for newborn ICU design. J Perinatol 43(S1):2–16. 10.1038/s41372-023-01784-4 European Standards of Care for Newborn Health Organisation of perinatal care. Published online 2021. Karlsson BM Sound and vibration: effects on infants’ heart rate and heart rate variability during neonatal transport. Acta Paediatr. Published online 2012. Grosek S, Mlakar G, Vidmar I, Primozic J, Ihan A Heart rate and leukocytes after air and ground transportation in artificially ventilated neonates: a prospective observational study. Intensive Care Med. Published online 2009. Mohamed MA Transport of premature infants is associated with increased risk for intraventricular haemorrhage. Arch Child Fetal Neonatal Ed. Published online 2010. Chen WH Neonatal mortality among outborn versus inborn babies. Pediatr Neonatol . Published online 2021 Sasaki Y, Ishikawa K, Yokoi A et al (2019) Short- and Long-Term Outcomes of Extremely Preterm Infants in Japan According to Outborn/Inborn Birth Status. Pediatr Crit Care Med. ;20(10) Mencuccini C, Silvestrini V (2016) Fisica. Meccanica e Termodinamica. CEA Tomao E, De Nuntiis F (2006) Le vibrazioni meccaniche: effetti sull’uomo. Scuola di Specializzazione Med del Lavoro La Sapienza Wieckowski D (2012) An attempt to estimate natural frequencies of parts of the child’s body. Automot Ind Inst Macnab A (1995) Vibration and noise in pediatric emergency transport vehicles: a potential cause of morbidity? Aviat Space Environ Med Bailey V, Szyld E, Cagle K et al Modern Neonatal Transport: Sound and Vibration Levels and Their Impact on Physiological Stability. Am J Perinatol. Published online 2019. Campbell A (1984) N. Mechanical vibration and sound levels experienced in neonatal transport. Am J Dis Child Howard GT, Baque E, Colditz PB et al (2023) Diagnostic accuracy of the Hammersmith Neonatal Neurological Examination in predicting motor outcome at 12 months for infants born very preterm. Dev Med Child Neurol 65(8):1061–1072. 10.1111/dmcn.15512 Lee SK, Zupancic JAF, Pendray M et al (2001) Transport risk index of physiologic stability: A practical system for assessing infant transport care. J Pediatr. ;139(2) Ambuel B (1992) Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol Inglesina, Aptica Inglesina S.p.A., Italia Fleming S, Thompson M, Stevens R et al (2011) Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet 377(9770):1011–1018. 10.1016/S0140-6736(10)62226-X Luna-Hernández G Utility of a physiologic stability index based on Transport Risk Index of Physiologic Stability (TRIPS) for the evaluation of infants transferred to a specialized hospital. Bol Med Hosp Infant Mex . Published online 2015 Qu W (2022) Comparison of four neonatal transport scoring methods in the prediction of mortality risk in full-term, out-born infants: a single-center retrospective cohort study. Eur J Pediatr Shah DM Utility of transport risk index of physiological stability score for predicting likely outcome of extramural neonates transferred to NICU. Int J Contemp Pediatr. Published online 2020. Meesters NJ (2023) COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates? J Perinatol Van Dijk M (2009) Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain The MathWorks Inc (2024) MATLAB Version: 24.1.0.2578822 (R2024a) Zhang N, Fard M, Bhuiyan MHU, Verhagen D, Azari MF, Robinson SR The Effects of Physical Vibration on Heart Rate Variability as a Measure of Drowsiness. Ergonomics . Published online 2018 BS ISO 2631- 1:1997 - Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration. BSI Standards Publication Skorup JC, Pierce SR, Ruwaih N, DeMauro SB, Johnson MJ, Prosser LA (2025) Hammersmith Neonatal and Infant Neurological Examinations Scores in Typically Developing Infants Aged 1–6 Months. J Child Neurol 40(1):10–14. 10.1177/08830738241282722 Romeo DM, Cowan FM, Haataja L et al (2021) Hammersmith Infant Neurological Examination for infants born preterm: predicting outcomes other than cerebral palsy. Dev Med Child Neurol 63(8):939–946. 10.1111/dmcn.14768 Tables Table 1 Association between physiological and behavioral data, adjusted for possible cofounders. Asterisks indicate significant associations (p < .05). CNS score CNS total CNS agitation CNS alertness CNS crying CNS facial tension CNS body movement CNS tone VTV 1.499 (p = .058) .487* (p = .008) .215 (p = .090) .220 (p = .173) .240 (p = .151) .211 (p = .270) .024 (p = .674) bpm 2.301 (p = .060) .134 (p = .430) .550* (p = .029) .235 (p = .297) .380 (p = .077) .554* (p = .035) .327 (p = .080) SpO 2 .683 (p = .585) − .234* (p = .037) .479 (p = .197) .070 (p = .707) − .380* (p < .001) − .039 (p = .834) .046 (p = .799) Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 23 Jun, 2025 Read the published version in European Journal of Pediatrics → Version 1 posted Editorial decision: Revision requested 30 May, 2025 Reviews received at journal 26 May, 2025 Reviewers agreed at journal 12 May, 2025 Reviewers invited by journal 02 May, 2025 Editor assigned by journal 28 Apr, 2025 Submission checks completed at journal 28 Apr, 2025 First submitted to journal 17 Apr, 2025 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. 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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-6474204","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":451685653,"identity":"d171ea13-00e9-47d3-9d1c-ec454be01b3d","order_by":0,"name":"Anna Trivillin","email":"","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":false,"prefix":"","firstName":"Anna","middleName":"","lastName":"Trivillin","suffix":""},{"id":451685655,"identity":"1396b380-b9c0-4d2e-8190-87ff16b6787b","order_by":1,"name":"Maria Elena Cavicchiolo","email":"data:image/png;base64,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","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":true,"prefix":"","firstName":"Maria","middleName":"Elena","lastName":"Cavicchiolo","suffix":""},{"id":451685658,"identity":"fdd0de1f-2663-4a58-9fa9-5a07578382be","order_by":2,"name":"Edoardo Passarotto","email":"","orcid":"","institution":"University of Padova","correspondingAuthor":false,"prefix":"","firstName":"Edoardo","middleName":"","lastName":"Passarotto","suffix":""},{"id":451685659,"identity":"363f2d61-5ad8-47e2-983d-e42f6506dfdf","order_by":3,"name":"Paola Contessa","email":"","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":false,"prefix":"","firstName":"Paola","middleName":"","lastName":"Contessa","suffix":""},{"id":451685663,"identity":"766d34e4-045c-4e0d-a986-6107a7c4b923","order_by":4,"name":"Alberto Trevisani","email":"","orcid":"","institution":"University of Padova","correspondingAuthor":false,"prefix":"","firstName":"Alberto","middleName":"","lastName":"Trevisani","suffix":""},{"id":451685664,"identity":"0b3329e5-57c5-4e76-a12f-ab1ebe59428b","order_by":5,"name":"Ivan Tomasi","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Ivan","middleName":"","lastName":"Tomasi","suffix":""},{"id":451685665,"identity":"860e43ff-125b-4c5e-a3c8-0f55d7852cc0","order_by":6,"name":"Giovanna Verlato","email":"","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":false,"prefix":"","firstName":"Giovanna","middleName":"","lastName":"Verlato","suffix":""},{"id":451685666,"identity":"2266a0f4-f819-4f85-9858-fa8e48dc03ff","order_by":7,"name":"Eugenio Baraldi","email":"","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":false,"prefix":"","firstName":"Eugenio","middleName":"","lastName":"Baraldi","suffix":""},{"id":451685667,"identity":"4cb168e5-9098-4ddf-ad9f-4dc131705a63","order_by":8,"name":"Stefano Masiero","email":"","orcid":"","institution":"University Hospital of Padova","correspondingAuthor":false,"prefix":"","firstName":"Stefano","middleName":"","lastName":"Masiero","suffix":""},{"id":451685668,"identity":"8c16c9a1-e7c1-4887-ab10-18b70fc9ab77","order_by":9,"name":"Maria Rubega","email":"","orcid":"","institution":"University of Padova","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"","lastName":"Rubega","suffix":""}],"badges":[],"createdAt":"2025-04-17 19:23:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6474204/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6474204/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00431-025-06273-8","type":"published","date":"2025-06-23T15:56:55+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82350451,"identity":"8bd1ab85-6855-4387-97b2-c5936189b931","added_by":"auto","created_at":"2025-05-09 10:52:09","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":290129,"visible":true,"origin":"","legend":"\u003cp\u003eFrom left to right, pram used in the study; placement of the neonatal SpO2 sensor and of the Inertial Measurement Units (IMU)s in the pram-infant-parent system; sections of the path including porphyry, gravel and asphalt.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6474204/v1/f852566d33f3859643e2b6de.png"},{"id":82350446,"identity":"af7162a0-66d4-47e7-9120-84720f8bbe96","added_by":"auto","created_at":"2025-05-09 10:52:08","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":56231,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003ePhysiological data\u003c/em\u003e. On the left column, the raw data, on the right column the data adjusted for age and weight. P-values from Wilcoxon signed-rank tests comparing data recorded on the three different terrains are reported. The first row reports the heart rate in bpm during 30 s with the pram on the asphalt (red), porphyry (green) and gravel (blue). The second row reports the cadence of the parent in step/min for each surface. The third row reports the percentage of oxygen saturation measured on the child’s foot for each surface. The fourth row reports the total value of the acceleration measured on the child’s thorax for each surface.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6474204/v1/6b4d7a978d36dc80f90efc69.png"},{"id":82351933,"identity":"f6a9243d-fffb-4659-a841-0125e7384692","added_by":"auto","created_at":"2025-05-09 11:00:08","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":101286,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eBehavioural data\u003c/em\u003e. On the left column, the raw data, on the right column the data adjusted for age and weight. Each row reports one parameter of the CNS.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6474204/v1/c24a9b4c2a11df8e631ad66b.png"},{"id":85686249,"identity":"cf21b434-c592-4797-9a2d-b9457133a543","added_by":"auto","created_at":"2025-06-30 16:05:12","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1203250,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6474204/v1/f8e84517-fbe3-4255-b665-1cee7296ab29.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eQuantitative Assessment of Comfort and Physiological Responses in Neonates and Infants During Transport: A Pilot Study\u003c/p\u003e","fulltext":[{"header":"What’s Known on This Subject","content":"\u003cp\u003eNeonatal and infant transport, both in and out of hospitals, causes significant stress due to mechanical vibrations. However, no specific regulations address vibration exposure, and its impact on overall physiological regulation remains poorly understood.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat This Study Adds:\u0026nbsp;\u003c/strong\u003eThis study included healthy newborns and infants instead of manikins, allowing a direct assessment of vital parameters and comfort in response to vibration exposure. Our findings demonstrate that different vibration levels may impact both behavioral and physiological parameters in this population.\u0026nbsp;\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eNeonatal well-being has become an increasingly central focus in modern neonatology, particularly for preterm infants, whose vulnerability demands greater attention to care conditions. In this context, the prevention and early recognition of pain, along with the minimization of environmental stressors such as noises and mechanical vibrations, are crucial to protecting neonatal health \u003csup\u003e1,2\u003c/sup\u003e. Neonatologists are increasingly prioritizing these goals, supported by recommendations from both the American Academy of Pediatrics and the World Health Organization, which advise that noise levels for newborns should not exceed 45 dB per hour \u003csup\u003e3\u0026ndash;5\u003c/sup\u003e. However, while guidelines for noise are well-defined, specific regulations for vibrations remain absent. Existing standards, designed primarily for adult occupational health, fail to address the unique vulnerabilities of neonates.\u003c/p\u003e\n\u003cp\u003eNeonatal transport represents a significant source of stress, particularly due to exposure to mechanical vibrations \u003csup\u003e6\u0026ndash;8\u003c/sup\u003e. Studies have shown an association between transport and increased mortality and morbidity, especially in preterm and low-birth-weight infants, attributed in part to their immature central nervous system and the physiological instability characteristic of this developmental stage \u003csup\u003e9,10\u003c/sup\u003e. However, the specific impact of vibrations overall physiological regulation remains poorly understood.\u003c/p\u003e\n\u003cp\u003eUnderstanding the phenomenon of resonance is crucial in this context. Resonance occurs when external vibrations align with the natural frequency of a tissue or organ, amplifying the applied forces and potentially causing harm \u003csup\u003e11,12\u003c/sup\u003e. While the resonance frequencies of adult tissues and organs are well-studied, no equivalent reference values exist for neonates \u003csup\u003e13\u003c/sup\u003e. This lack of data underscores the need for research aimed at identifying harmful vibration intensities and establishing safety thresholds to protect this vulnerable population. Although current research has shed light on vibration exposure during air and ambulance transport \u003csup\u003e14\u0026ndash;16\u003c/sup\u003e, safety thresholds for neonates remain undefined. \u0026nbsp;It is known that tone and posture in newborns and infants differ significantly from those of adults because of the developmental and neurological immaturity present in early life: in the first six months of life individuals do not have complete head control and exhibit a physiological flexion posture \u003csup\u003e17\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe safety and the health of newborns are typically evaluated using specific comfort and risk assessment scores. The TRIPS (Transport Risk Index of Physiologic Stability) score is a clinical tool used to assess the risk of physiologic instability in neonates during transport, whether intra-hospital or between healthcare facilities. This score helps predict outcomes by evaluating a neonate\u0026apos;s condition at the time of transport, with higher TRIPS scores indicating greater physiologic instability and a higher risk of adverse outcomes \u003csup\u003e18\u003c/sup\u003e. Additionally, several validated pain scales have been developed specifically for newborns, considering their unique developmental and physiological characteristics, which require specialized tools to assess pain. These scales primarily rely on behavioral and physiological indicators, as newborns cannot verbally express pain. Among these, the Comfort Neo Scale (CNS) is a particularly valuable tool for assessing pain and discomfort in neonates, offering an objective method to measure their comfort and distress levels \u003csup\u003e19\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThis study aims to assess if physiological data are descriptive of behavioural data and if vibration exposure levels during neonatal transport in a pram affect neonatal well-being, focusing on physiological stability and comfort.\u0026nbsp;\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eThis study was conducted at the University Hospital of Padua between June and October 2024. The study, titled \u003cstrong\u003e\u0026ldquo;\u003c/strong\u003eQuantification of Child Well-being\u003cstrong\u003e\u0026rdquo;\u003c/strong\u003e (ID 22835, URC Code AOP3233), was coordinated by the Department of Neurosciences at the University of Padua in collaboration with Padua Neonatal Intensive Care Unit (NICU). Ethical approval was obtained from the Territorial Ethics Committee (5934/AO/24) on May 9, 2024.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eParticipants\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study included term neonates and infants, aged 0 to 6 months, with normal perinatal conditions and no active diseases. Written informed consent was obtained from both parents. Preterm neonates and those with acute or chronic medical conditions were excluded.\u003c/p\u003e\n\u003cp\u003ePrior to participation, all subjects underwent a standardized pediatric examination, including vital parameters assessment. Neurological evaluations were conducted using the Hammersmith Neonatal Neurological Examination (HNNE) for neonates and the Hammersmith Infant Neurological Examination (HINE) for infants \u003csup\u003e30,31\u003c/sup\u003e, focusing on posture and axial and appendicular tone.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTransport Test\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe transport test involved the use of a modern pram \u003csup\u003e20\u003c/sup\u003e over asphalt, porphyry and gravel, while the parent pushed the pram in a forward direction (straight line). No ascending or descending paths were considered. The total transport duration was approximately 15 minutes. Data collection was performed in an outdoor setting to simulate real-life conditions.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eVibration Measurement\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eVibrations during transport were recorded using the Wave Plus system by Cometa (Milan), which simultaneously captures acceleration (g) and angular velocity (\u0026deg;/s) data from inertial measurement units (IMUs) with a sampling frequency of 284 Hz (operating temperature range: [0-50]◦C , acceleration measurement range: \u0026plusmn; 16 g, dimension: 32x17x12 mm, weight: 10-14 g). Sensors were positioned on the infant\u0026rsquo;s body (trunk) and on the ankle of the mother pushing the pram (Fig. 1). Data visualization and processing were performed in MATLAB.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePhysiological Parameters and Behavioral Assessment\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePhysiological parameters (heart rate, blood pressure, oxygen saturation, respiratory rate, and body temperature) were recorded at the beginning and end of transport. Continuous monitoring of heart rate and oxygen saturation was performed using a neonatal SpO2 sensor (Radical-7 Pulse CO-Oximeter,\u0026nbsp;Masimo). The heart rate during transport was also extracted from the data provided by a sensor placed on the child\u0026apos;s chest. The reference range for vital parameters was based on values previously published, stratified by age \u003csup\u003e21\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Transport Risk Index of Physiologic Stability (TRIPS) \u003csup\u003e18,22\u0026ndash;24\u003c/sup\u003e score was used to assess the physiological stability of neonates before and after transport. Neonatal comfort was evaluated at five distinct points during the test using the Comfort Neo Scale (CNS)\u003csup\u003e25,26\u003c/sup\u003e, which assesses seven behavioral parameters. A TRIPS score below 10 indicates no significant illness severity, while CNS values less than or equal to 14 were interpreted as indicating no signs of discomfort. For each transport, a video was recorded, allowing for multiple evaluations of the same participant by different clinicians to ensure reliability.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData Analysis\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eDescriptive statistical analyses were conducted on clinical data. Vibration signal analysis was performed using MATLAB 2024a \u003csup\u003e27\u003c/sup\u003e, computing the vibration total value (VTV) on the infants\u0026rsquo; trunk as the square root of the sum of the root mean square (rms) values on the detrended acceleration data along the x axis (along the direction of movement), y axis (parallel to the ground and perpendicular to the direction of movement) and z axis (parallel to the gravity) measured in m/s\u0026sup2; for at least 30 seconds on each terrain segment. Raw data were detrended to remove time-varying drifts and the gravity components. The frequency weighting proposed in ISO 2631-1 was not applied because sensors were directly on the person and not on the contact surface between the person and the means of transport. Results were visualized using boxplots to assess data distribution and variability.\u003c/p\u003e\n\u003cp\u003eRegression analyses were performed using R 4.1 to investigate the association between physiological and behavioral data, controlling for possible cofounders (i.e. age, weight). significance was set at p \u0026gt; 0.05. Statistically significant results are indicated by an asterisk. Positive values indicate that both variables increase or decrease together. Negative values indicate that the variables move in opposite directions.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 18 neonates and infants who met the eligibility criteria were included in the study. The average age was 102 days (range: 18-179), with a median of 93 days. The average weight was 5.87 kg (range: 2.8-8.8), with a median of 5.5 kg.\u003c/p\u003e\n\u003cp\u003eAt the initial medical examination, all subjects had a regular clinical examination and vital parameters within normal ranges. Muscle tone and posture, assessed using the Hammersmith Neurological Examination according to the subject\u0026apos;s age, were appropriate for their developmental stage. The average comfort score, evaluated using the CNS, was 14 (range: 6-20), with a median of 15 at baseline. Physiological stability, assessed using the TRIPS score, recorded an average of 1.4 (range: 0-8), with a median of 1 at the beginning of the transport.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eVibration Transmission\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe vibration patterns in the time domain transmitted to the pram-neonate system were similar across the different samples. A higher intensity of vibrations was observed on the gravel section compared to the other segments of the path.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMedian vibration intensity, measured as vibration total value (VTV), ranged, on average, from 1.10 to 2.71 m/s\u0026sup2;, with the highest values recorded on gravel surfaces (Fig. 2, fourth row).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eVital Parameters Evaluation\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003c/strong\u003eHeart rate analysis revealed no significant variations over time, remaining within normal ranges throughout the transport. On uneven surfaces, a slight increase in the median heart rate was observed (Fig. 2, first row).\u003c/p\u003e\n\u003cp\u003eContinuous monitoring of SpO\u003csub\u003e2\u003c/sub\u003e levels showed stability with no significant variations during transport, remaining within normal ranges. Outlier values were associated with episodes of infant crying, where temporary loss of the oximeter signal may have influenced the data (Fig. 2, third row).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePhysiological Stability Evaluation\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003c/strong\u003eNo significant differences in physiological stability, assessed using the TRIPS score, were observed before and after transport. At the end of the transport, the TRIPS score showed a mean of 1.5 (range: 0-6), with a median of 1, unchanged from baseline (Fig. 3).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eComfort Evaluation\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003c/strong\u003eComfort, measured using the CNS, showed considerable variability between subjects. The median CNS score was lower on the porphyry segment compared to others (Fig. 3). Notably there was a slight reduction in alertness and mobility on the porphyry and gravel segments.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRelationship between vibrations, comfort and physiological parameters adjusting for weight and age\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe found that all parameters were correlated with the weight and age of the child [|r| = .069 - .438]. This suggests us to consider age and weight as cofounders (Fig.2 and Fig. 3).\u003c/p\u003e\n\u003cp\u003eAdjusting data for weight and age we notice that physiological parameters (VTV, bpm and SpO\u003csub\u003e2\u003c/sub\u003e) are related to some behavioural parameters: higher VTV values were associated with greater agitation scores (r = .487, p = .008); higher bpm values were associated with greater alertness (r = .550, p = .029) and body movement scores (r = .554, p = .035); lower oxygen saturation values were associated with greater agitation (r = -.234, p = .037) and facial tension scores (r = -.380, p \u0026gt; .001).\u003c/p\u003e\n\u003cp\u003eThe results also suggest a tendency for the state of alertness to decrease as the perceived vibrations increase (Table 1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e Association between physiological and behavioral data, adjusted for possible cofounders. Asterisks indicate significant associations (p \u0026lt; .05).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"601\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS total\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS agitation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS alertness\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS crying\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS facial tension\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS body movement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCNS tone\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVTV\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e1.499\u003c/p\u003e\n \u003cp\u003e(p = .058)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73px;\"\u003e\n \u003cp\u003e.487*\u003c/p\u003e\n \u003cp\u003e(p = .008)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e.215\u003c/p\u003e\n \u003cp\u003e(p = .090)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e.220\u003c/p\u003e\n \u003cp\u003e(p = .173)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e.240\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(p = .151)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e.211\u003c/p\u003e\n \u003cp\u003e(p = .270)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e.024\u003c/p\u003e\n \u003cp\u003e(p = .674)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ebpm\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e2.301\u003c/p\u003e\n \u003cp\u003e(p = .060)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73px;\"\u003e\n \u003cp\u003e.134\u003c/p\u003e\n \u003cp\u003e(p = .430)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e.550*\u003c/p\u003e\n \u003cp\u003e(p = .029)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e.235\u003c/p\u003e\n \u003cp\u003e(p = .297)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e.380\u003c/p\u003e\n \u003cp\u003e(p = .077)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e.554*\u003c/p\u003e\n \u003cp\u003e(p = .035)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e.327\u003c/p\u003e\n \u003cp\u003e(p = .080)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSpO\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003e2\u003c/sub\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e.683\u003c/p\u003e\n \u003cp\u003e(p = .585)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73px;\"\u003e\n \u003cp\u003e-.234*\u003c/p\u003e\n \u003cp\u003e(p = .037)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e.479\u003c/p\u003e\n \u003cp\u003e(p = .197)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e.070\u003c/p\u003e\n \u003cp\u003e(p = .707)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e-.380*\u003c/p\u003e\n \u003cp\u003e(p \u0026lt; .001)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e-.039\u003c/p\u003e\n \u003cp\u003e(p = .834)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e.046\u003c/p\u003e\n \u003cp\u003e(p = .799)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis pilot study analyzed the impact of vibrations during \u0026quot;recreational\u0026quot; transportation in a commercial pram across different terrains on vital parameters and comfort in 18 healthy subjects aged 0-6 months.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo our knowledge, this is the first study which analyzed comfort and vibration transmissions during a transport with a commercial pram, which is typically considered the safest and the most comfortable transport means for healthy newborns and infants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur findings demonstrate that vibrations can influence both comfort and vital parameters, even in a recreational setting, although all observed changes remain within safe ranges.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe found that all parameters are correlated with the weight and age of the child: \u0026nbsp;the smaller the infants, the more susceptible they are to the effects of vibrations. As expected, we observed that physiological parameters such as vibration total value recorded at the infants\u0026rsquo; trunk (VTV), heart rate (bpm) and oxygen saturation (SpO₂) were significantly associated with behavioral responses: VTV were positively correlated with agitation scores; higher bpm values were associated with greater alertness and increased body movement scores; lower oxygen saturation values correlated with increased agitation and facial tension scores. Furthermore, our results suggest a trend where higher perceived vibration levels are associated with a decrease in alertness, a phenomenon previously documented in adult studies \u003csup\u003e28\u003c/sup\u003e. This highlights the potential impact of prolonged vibration exposure on neonatal behavioral states.\u003c/p\u003e\n\u003cp\u003eVibration intensity (VTV) ranged, on average, from 1.10 to 2.71 m/s\u0026sup2;, depending on terrain type, with the highest values observed on gravel. Comparisons with prior studies on neonatal transport in ambulance and aircraft show that whole-body vibrations in those settings range from 0.04 to 5.6 m/s\u0026sup2;, with higher peaks occurring in air transport \u003csup\u003e14,15\u003c/sup\u003e. As neonatal-specific vibration assessment methods are unavailable, using workplace standards for adults it seems that the recorded accelerations exceed the \u0026quot;comfortable\u0026quot; thresholds for adults (ISO 2631-1:1997) \u003csup\u003e29\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDespite these findings, changes in vital parameters, physiological stability (TRIPS score), or comfort (CNS) observed during transport remain in safe ranges. This outcome was expected given the study\u0026rsquo;s short transport duration, the infants\u0026rsquo; healthy status, and the cushioning effect of the pram. Interestingly, increased exposure to vibrations was associated with a higher CNS score, suggesting a potential link between vibration intensity and infant discomfort. While our study provides an initial understanding of these interactions, further research is needed to determine whether longer exposure durations or higher vibration levels could have more pronounced physiological or behavioral effects.\u003c/p\u003e\n\u003cp\u003eOne of the main strengths of this study is the use of newborns and infants instead of manikins, allowing for a direct assessment of vital parameters and comfort in response to vibration exposure. Previous studies that included real infants did not integrate clinical data with vibration and sound exposure measurements, often relying on adult reference standards \u003csup\u003e15,16\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHowever, several limitations of our study should be considered. First, the lack of standardized methods for assessing neonatal exposure to vibrations makes direct comparisons with other studies challenging. Additionally, comfort evaluation is inherently subjective and may be influenced by environmental factors such as temperature, lighting, and noise, introducing potential bias in the results. Another challenge is the technical limitations of monitoring devices, as signal loss\u0026mdash;particularly during episodes of infant crying\u0026mdash;may have affected the accuracy of some physiological measurements. To address these issues, future research should focus on refining measurement techniques and developing neonatal-specific assessment criteria.\u003c/p\u003e\n\u003cp\u003eLooking ahead, further studies should explore longer transport durations to assess potential cumulative effects of vibration exposure on neonatal physiology and behavior. Investigations focusing on intra- and inter-hospital transport\u0026mdash;where vibration levels are typically higher\u0026mdash;are particularly needed. Additionally, advancements in vibration-damping technologies and more precise neonatal monitoring tools will be crucial for improving the safety and comfort of transported infants. These efforts will contribute to the development of evidence-based safety guidelines for neonatal transport.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn this pilot study, we applied a method to quantitatively assess comfort and the effects of vibration during transport in newborns and infants. Our findings demonstrate that different vibration levels may impact both behavioral and physiological parameters in this population. Applying this protocol to real-world transport scenarios, including intra- and inter-hospital transfers, could help establish safer vibration thresholds for neonates and infants.\u003c/p\u003e\n\u003cp\u003eDefining specific safety standards for neonatal transport remains crucial. Future research should focus on refining measurement techniques, addressing current methodological limitations, and investigating a broader range of transport conditions. These efforts will be essential in developing evidence-based guidelines that enhance neonatal transport practices, ensuring both safety and long-term well-being for this vulnerable population.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCNS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eComfort Neo Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIMUs\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInertial measurement units\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNICU\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNeonatal Intensive Care Unit\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRMS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRoot mean square\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTRIPS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTransport Risk Index of Physiologic Stability\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVTV\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVibration Total Value\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of Interest Disclosures:\u003c/strong\u003e Ivan Tomasi is a legal representative of L'Inglesina Baby SpA. The authors declare no other potential conflicts of interest relevant to this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding/Support:\u0026nbsp;\u003c/strong\u003eThis study was supported by \"Ministero delle Imprese e del Made in Italy\" (D.M. MISE 31/12/2021 – Accordi per l’innovazione - Id: 10210 - MISE 127 - DESIGN FOR BABY WELLNESS). Maria Rubega and Edoardo Passarotto are supported by the European Union- Next Generation EU, Mission 4 Component 1 (CUP C53D23006170006).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eContributors Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDr Anna Trivillin and Dr Maria Elena Cavicchiolo collected the data and wrote the manuscript.\u003c/p\u003e\n\u003cp\u003eDr Maria Rubega collected the data, conceived the experiment and coordinated the data collection and analysis.\u003c/p\u003e\n\u003cp\u003eDr Paola Contessa collected the data and conceived the experiment.\u003c/p\u003e\n\u003cp\u003eDr Edoardo Passarotto performed the statistical analysis.\u003c/p\u003e\n\u003cp\u003eProf Alberto Trevisani supervised the experiment and the analysis.\u003c/p\u003e\n\u003cp\u003eEng. Ivan Tomasi supervised the experiment and the analysis.\u003c/p\u003e\n\u003cp\u003eProf Stefano Masiero obtained the Ethical Committee clearance and conceived the experiment.\u003c/p\u003e\n\u003cp\u003eProf Eugenio Baraldi and Dr Giovanna Verlato commented and approved all the drafts of the manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll the authors read and approved the final version of the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGrunau RE (2013) Neonatal Pain in Very Preterm Infants: Long-Term Effects on Brain, Neurodevelopment and Pain Reactivity. Rambam Maimonides Med J. ;4(4)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGiordano V (2023) Pain and neurodevelopmental outcomes of infants born very preterm. 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J Pediatr Psychol\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eInglesina, Aptica Inglesina S.p.A., Italia\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFleming S, Thompson M, Stevens R et al (2011) Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet 377(9770):1011\u0026ndash;1018. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S0140-6736(10)62226-X\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(10)62226-X\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLuna-Hern\u0026aacute;ndez G Utility of a physiologic stability index based on Transport Risk Index of Physiologic Stability (TRIPS) for the evaluation of infants transferred to a specialized hospital. \u003cem\u003eBol Med Hosp Infant Mex\u003c/em\u003e. Published online 2015\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQu W (2022) Comparison of four neonatal transport scoring methods in the prediction of mortality risk in full-term, out-born infants: a single-center retrospective cohort study. Eur J Pediatr\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShah DM Utility of transport risk index of physiological stability score for predicting likely outcome of extramural neonates transferred to NICU. Int J Contemp Pediatr. Published online 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeesters NJ (2023) COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates? J Perinatol\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVan Dijk M (2009) Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eThe MathWorks Inc (2024) MATLAB Version: 24.1.0.2578822 (R2024a)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang N, Fard M, Bhuiyan MHU, Verhagen D, Azari MF, Robinson SR The Effects of Physical Vibration on Heart Rate Variability as a Measure of Drowsiness. \u003cem\u003eErgonomics\u003c/em\u003e. Published online 2018\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBS ISO 2631- 1:1997 - Mechanical vibration and shock \u0026mdash; Evaluation of human exposure to whole-body vibration. \u003cem\u003eBSI Standards Publication\u003c/em\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSkorup JC, Pierce SR, Ruwaih N, DeMauro SB, Johnson MJ, Prosser LA (2025) Hammersmith Neonatal and Infant Neurological Examinations Scores in Typically Developing Infants Aged 1\u0026ndash;6 Months. J Child Neurol 40(1):10\u0026ndash;14. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/08830738241282722\u003c/span\u003e\u003cspan address=\"10.1177/08830738241282722\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRomeo DM, Cowan FM, Haataja L et al (2021) Hammersmith Infant Neurological Examination for infants born preterm: predicting outcomes other than cerebral palsy. Dev Med Child Neurol 63(8):939\u0026ndash;946. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/dmcn.14768\u003c/span\u003e\u003cspan address=\"10.1111/dmcn.14768\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv id=\"13\" class=\"btn-xs-small Annotation tooltipped\" data-position=\"top\" data-tooltip=\"\"\u003e\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAssociation between physiological and behavioral data, adjusted for possible cofounders. Asterisks indicate significant associations (p\u0026thinsp;\u0026lt;\u0026thinsp;.05).\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS score\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS total\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS agitation\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS alertness\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS crying\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS facial tension\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS body movement\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCNS tone\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003eVTV\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.499\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.058)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.487*\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.008)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.215\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.090)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.220\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.173)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.240\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.151)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.211\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.270)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.024\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.674)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003ebpm\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.301\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.060)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.134\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.430)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.550*\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.029)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.235\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.297)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.380\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.077)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.554*\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.035)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.327\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.080)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003eSpO\u003c/span\u003e\u003csub\u003e\u003cspan type=\"Bold\" class=\"Bold\" name=\"Emphasis\"\u003e2\u003c/span\u003e\u003c/sub\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.683\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.585)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u0026minus;\u0026thinsp;.234*\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.037)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.479\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.197)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.070\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.707)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u0026minus;\u0026thinsp;.380*\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;\u0026lt;\u0026thinsp;.001)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u0026minus;\u0026thinsp;.039\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.834)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e.046\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e(p\u0026thinsp;=\u0026thinsp;.799)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\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":"european-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejpe","sideBox":"Learn more about [European Journal of Pediatrics](https://www.springer.com/journal/431)","snPcode":"431","submissionUrl":"https://submission.nature.com/new-submission/431/3","title":"European Journal of Pediatrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"neonatal comfort, neonatal transport, safety threshold, mechanical vibration","lastPublishedDoi":"10.21203/rs.3.rs-6474204/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6474204/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e: Minimizing environmental stressors is crucial for neonatal health. The American Academy of Pediatrics and the World Health Organization have issued recommendations to limit noise levels for newborns, but no specific regulations currently address vibration exposure.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Objective\u003c/strong\u003e: To quantitatively assess comfort and physiological stability in neonates and infants during a pram transport.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods: \u003c/strong\u003eHealthy neonates and infants (\u0026lt;6 months old) were enrolled for a 15-min walk using a commercially available pram over different surfaces. Vibrations were recorded using accelerometers, while physiological parameters were monitored with a neonatal SpO₂ sensor. Comfort and physiological scores were assessed using the Transport Risk Index of Physiologic Stability score and Comfort Neo Scale.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Eighteen subjects (median age: 93 days, IQR [59, 158]; median weight: 5.5 kg (IQR [5, 7.5]) were included. Median vibration total value ranged from 1.10 to 2.71 m/s², with the highest values recorded on gravel surfaces. Higher vibration total values correlated with greater agitation scores (r = .487, p = .008). Increased heart rate was associated with greater alertness (r = .550, p = .029) and body movement (r = .554, p = .035). Lower oxygen saturation correlated with increased agitation (r = -.234, p = .037) and facial tension (r = -.380, p \u0026gt; .001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eMechanical vibrations during pram transport were associated with behavioral changes in neonates and infants, with higher vibration exposure correlating with greater agitation scores. These findings highlight the need for further research to define safe vibration exposure thresholds, particularly for hospital neonatal transport.\u003c/p\u003e","manuscriptTitle":"Quantitative Assessment of Comfort and Physiological Responses in Neonates and Infants During Transport: A Pilot Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-09 10:52:04","doi":"10.21203/rs.3.rs-6474204/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-05-30T07:44:09+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-26T10:16:50+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"72266832319193113991669534852990421799","date":"2025-05-12T10:05:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-05-02T14:12:12+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-04-28T06:37:21+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-28T06:33:41+00:00","index":"","fulltext":""},{"type":"submitted","content":"European Journal of Pediatrics","date":"2025-04-17T19:09:15+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejpe","sideBox":"Learn more about [European Journal of Pediatrics](https://www.springer.com/journal/431)","snPcode":"431","submissionUrl":"https://submission.nature.com/new-submission/431/3","title":"European Journal of Pediatrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"856a9afa-1db1-42a9-b38d-c7837c7f882b","owner":[],"postedDate":"May 9th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-06-30T16:03:12+00:00","versionOfRecord":{"articleIdentity":"rs-6474204","link":"https://doi.org/10.1007/s00431-025-06273-8","journal":{"identity":"european-journal-of-pediatrics","isVorOnly":false,"title":"European Journal of Pediatrics"},"publishedOn":"2025-06-23 15:56:55","publishedOnDateReadable":"June 23rd, 2025"},"versionCreatedAt":"2025-05-09 10:52:04","video":"","vorDoi":"10.1007/s00431-025-06273-8","vorDoiUrl":"https://doi.org/10.1007/s00431-025-06273-8","workflowStages":[]},"version":"v1","identity":"rs-6474204","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6474204","identity":"rs-6474204","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}