An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India

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With a focus on neonates admitted to the Neonatal Intensive Care Unit (NICU) at Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India, the research aims to contribute valuable insights into the physiological changes associated with this common neonatal condition. The study’s introduction highlights the rationale, significance, and gaps in current knowledge, emphasising the need for a detailed exploration of electrolyte dynamics before and after phototherapy. Method The methodology involves a descriptive, interventional cross-sectional design with a calculated sample size of 264 neonates. Standardised protocols for data collection, including serum electrolyte analysis and urine-specific gravity assessment, will be employed. Inclusion and exclusion criteria are clearly defined to ensure a homogenous study population. Statistical analyses, utilising R Studio 4.3.1 will encompass descriptive statistics, comparative analysis, correlation analysis, and multivariate analysis to explore the nuanced relationships between variables. Rigorous ethical considerations and transparency in reporting will guide the data collection process. Expected Result Anticipated outcomes include a nuanced understanding of changes in serum electrolyte levels following phototherapy and the correlation of these changes with the treatment duration. The study is poised to shed light on the impact of gestational age and birth weight on electrolyte responses. Through rigorous statistical analysis, the research aims to provide evidence-based insights that can inform neonatal care protocols. The anticipated findings hold the potential to influence clinical practices, enhancing the quality of care provided to newborns with hyperbilirubinemia undergoing phototherapy. 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F1000Research 2024, 13 :469 ( https://doi.org/10.12688/f1000research.144931.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] Ankita Kiran Patel https://orcid.org/0009-0008-9659-2085 1 , Jayant Vagha 1 Ankita Kiran Patel https://orcid.org/0009-0008-9659-2085 1 , Jayant Vagha 1 PUBLISHED 09 May 2024 Author details Author details 1 Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India Ankita Kiran Patel Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Jayant Vagha Roles: Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Introduction This study protocol outlines a comprehensive investigation into the impact of phototherapy on electrolyte levels in newborns with hyperbilirubinemia. With a focus on neonates admitted to the Neonatal Intensive Care Unit (NICU) at Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India, the research aims to contribute valuable insights into the physiological changes associated with this common neonatal condition. The study’s introduction highlights the rationale, significance, and gaps in current knowledge, emphasising the need for a detailed exploration of electrolyte dynamics before and after phototherapy. Method The methodology involves a descriptive, interventional cross-sectional design with a calculated sample size of 264 neonates. Standardised protocols for data collection, including serum electrolyte analysis and urine-specific gravity assessment, will be employed. Inclusion and exclusion criteria are clearly defined to ensure a homogenous study population. Statistical analyses, utilising R Studio 4.3.1 will encompass descriptive statistics, comparative analysis, correlation analysis, and multivariate analysis to explore the nuanced relationships between variables. Rigorous ethical considerations and transparency in reporting will guide the data collection process. Expected Result Anticipated outcomes include a nuanced understanding of changes in serum electrolyte levels following phototherapy and the correlation of these changes with the treatment duration. The study is poised to shed light on the impact of gestational age and birth weight on electrolyte responses. Through rigorous statistical analysis, the research aims to provide evidence-based insights that can inform neonatal care protocols. The anticipated findings hold the potential to influence clinical practices, enhancing the quality of care provided to newborns with hyperbilirubinemia undergoing phototherapy. READ ALL READ LESS Keywords Hyperbilirubinemia, Phototherapy, Neonates, Electrolyte levels, Newborn care, Tertiary care hospital Corresponding Author(s) Ankita Kiran Patel ( [email protected] ) Close Corresponding author: Ankita Kiran Patel Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Kiran Patel A and Vagha J. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Kiran Patel A and Vagha J. An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.12688/f1000research.144931.1 ) First published: 09 May 2024, 13 :469 ( https://doi.org/10.12688/f1000research.144931.1 ) Latest published: 09 May 2024, 13 :469 ( https://doi.org/10.12688/f1000research.144931.1 ) Introduction Neonatal hyperbilirubinemia remains a prevalent concern in newborn care, often necessitating interventions such as phototherapy for effective management. This study protocol delves into the intricate dynamics of electrolyte levels in neonates with hyperbilirubinemia, seeking to enhance our understanding of the physiological impact of phototherapy. According to the World Health Organization (WHO), approximately 60% of full-term newborns and 80% of preterm newborns experience jaundice, highlighting the significance of investigating therapeutic modalities for hyperbilirubinemia. 1 While phototherapy is a widely adopted treatment, the specific effects on serum electrolyte levels in neonates remain a subject of exploration. 2 Previous studies have focused on the efficacy of phototherapy in reducing bilirubin levels, but a comprehensive understanding of its influence on electrolyte balance is yet to be elucidated. 3 Electrolyte imbalances in neonates can have profound consequences, impacting various physiological processes, including renal function and neuromuscular excitability. 4 This study, conducted at the Neonatology unit in Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India, aims to bridge this knowledge gap. We aspire to unravel the intricate relationship between phototherapy and changes in serum electrolyte levels by employing a descriptive, interventional cross-sectional design and a meticulously calculated sample size. Rigorous statistical analyses, guided by ethical considerations, will contribute to the academic discourse and inform evidence-based neonatal care protocols. The significance of this research lies in its potential to offer nuanced insights that may shape clinical practices, ultimately improving outcomes for neonates with hyperbilirubinemia undergoing phototherapy. Through the lens of this study, we aspire to contribute to the ongoing efforts to enhance the quality of care and outcomes for newborns, addressing a crucial aspect of neonatal health. Aim This study’s primary aim is to investigate phototherapy’s impact on electrolyte levels in newborns with hyperbilirubinemia, thereby enhancing our understanding of the physiological changes associated with this common neonatal condition. Objectives 1. To assess serum electrolyte levels: Determine and compare the levels of essential electrolytes (Sodium, Potassium, Calcium) in the serum of newborns with hyperbilirubinemia before and after the administration of phototherapy. 2. To evaluate urine specific gravity levels: Examine and compare the specific urine gravity levels in newborns with hyperbilirubinemia before and after phototherapy, providing insights into potential changes in renal function. 3. To correlate electrolyte changes with phototherapy: Establish a correlation between the changes in serum electrolyte levels and the duration/intensity of phototherapy, elucidating the relationship between the treatment and its physiological impact. 4. To determine day-of-life impact: Investigate any variations in electrolyte levels concerning the day of life, recognising potential developmental patterns or trends. 5. To explore gestational age and birth weight influence: Analyze the potential influence of gestational age and birth weight on the electrolyte response to phototherapy, contributing to a comprehensive understanding of individualised treatment effects. Methods Study design This study adopts a descriptive, interventional cross-sectional design to comprehensively analyse electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy. Study population The study population comprises neonates admitted to the Department of Pediatrics Neonatology unit at Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India. Place of study The research will be conducted within the confines of the Neonatology unit, providing a controlled and specialised environment for the study. Inclusion and exclusion criteria Inclusion criteria: 1. Neonates admitted to the Neonatal Intensive Care Unit (NICU). 2. Neonates diagnosed with hyperbilirubinemia. 3. Neonates undergoing phototherapy. 4. Neonates with a minimum age of 24 hours. Exclusion criteria: 1. Neonates with Conjugated Hyperbilirubinemia. 2. Neonates requiring intravenous (IV) fluid and intensive care. 3. Neonates exclusively formula-fed. 4. Neonates with co-morbidities, such as acute renal failure. Bias To minimise potential biases in the study, several measures will be implemented: 1. Selection bias: • To mitigate selection bias, the inclusion and exclusion criteria are clearly defined and strictly adhered to during enrollment. • Random sampling methods will be employed to select eligible neonates, reducing the likelihood of systematic bias in participant selection. 2. Information bias: • Standardized protocols for data collection will be established and followed rigorously to ensure consistency and accuracy. • Researchers will be trained to collect data uniformly, reducing the chances of information bias. Enrollment 1. Recruitment: • Neonates meeting the inclusion criteria will be recruited from the NICU after obtaining informed consent from their parents or legal guardians. 2. I nformed consent: • A detailed information sheet in the local language will be provided to parents, explaining the study’s purpose, procedures, potential risks, and benefits. Informed written consent will be obtained before enrollment. 3. Ethical considerations: • Ethical approval has been obtained and written informed consent will be taken before the commencement of the study, ensuring that ethical standards are met throughout the research process. 4. Transparent reporting: • The enrollment process, including the number of eligible and enrolled participants, will be reported transparently to allow for external scrutiny and assessment of potential selection biases. Data collection process The data collection process for this study will involve a systematic and meticulous approach to ensure the acquisition of accurate and reliable information. Trained research personnel with a standardised data collection protocol will gather the necessary data from the enrolled neonates and their medical records. Upon admission to the Neonatal Intensive Care Unit (NICU), eligible neonates meeting the inclusion criteria will be identified. The research team will approach these neonates’ parents or legal guardians, and a detailed information sheet will be provided in the local language, explaining the study’s purpose, procedures, and potential implications. Informed written consent will be obtained from those willing to participate. The data collection will include the day of life, serum electrolyte levels (specifically Sodium, Potassium, and Calcium), gestational age, and birth weight. Trained researchers will employ standard measurement techniques and calibrate instruments to collect blood samples for serum electrolyte analysis. To assess urine-specific gravity levels, non-invasive methods will be employed, with urine samples collected before and after the administration of phototherapy. The timing and duration of phototherapy will be carefully documented to explore potential correlations between electrolyte changes and the treatment regimen. A detailed case report form (CRF) will systematically record the gathered information. The CRF will include sections for demographic details, medical history, laboratory results, and details of phototherapy. The research team will ensure the confidentiality and privacy of the collected data, assigning unique identifiers to each participant to maintain anonymity. Regular training sessions for the research personnel will be conducted to reinforce adherence to the standardised data collection procedures, minimising the risk of observer bias. Additionally, periodic quality checks and data audits will be performed to ensure the accuracy and completeness of the collected data. Ethical considerations will be paramount throughout the data collection process, with strict adherence to privacy regulations and respect for the participants’ autonomy. The collected data will be securely stored and only accessible to the authorised research team members, contributing to the integrity and validity of the study outcomes. Sample size The sample size for this study was determined using a formula that considers various parameters. In this case, with a population size of 10,000, a percentage frequency of hypocalcemia in neonates receiving phototherapy set at 22% (or 0.22), and a confidence limit of 5%, the calculated sample size is 264. The formula incorporates a design effect (DEFF), which, in this instance, is considered as 1. The confidence level chosen for the study is 95%, represented by the Z-score corresponding to the critical value of 1.96. This calculated sample size of 264 is expected to provide a robust representation of the population, ensuring a suitable level of confidence and precision in estimating the frequency of hypocalcemia in neonates undergoing phototherapy for hyperbilirubinemia within the given population size. Expected outcome 1. Changes in serum electrolyte levels: The study expects to observe changes in serum electrolyte levels, particularly Sodium, Potassium, and Calcium, before and after the administration of phototherapy. Any significant alterations in these electrolytes may shed light on the physiological response of newborns to phototherapy. 2. Correlation with phototherapy: The research aims to establish a correlation between the duration and intensity of phototherapy and the observed changes in serum electrolyte levels. Understanding this correlation could aid healthcare providers in optimising phototherapy regimens for neonates with hyperbilirubinemia. 3. Urine-specific gravity levels: The study anticipates variations in urine-specific gravity levels before and after phototherapy, providing insights into the renal impact of the treatment. This information could be crucial for assessing renal function in neonates undergoing phototherapy. 4. Day-of-life impact: The research will explore whether there are variations in electrolyte levels based on the day of life, potentially identifying patterns or trends in the response to phototherapy at different stages of neonatal development. 5. Influence of gestational age and birth weight: The study aims to analyse the influence of gestational age and birth weight on the electrolyte response to phototherapy. This information could contribute to a better understanding of individualised treatment effects based on neonatal characteristics. 6. Clinical implications: The expected outcomes can inform clinical decision-making in the management of hyperbilirubinemia in neonates. Understanding the electrolyte changes associated with phototherapy may guide healthcare professionals in tailoring treatment plans for improved efficacy and safety. 7. Contribution to neonatal care guidelines: Positive findings from the study may contribute to developing or modifying neonatal care guidelines, providing evidence-based recommendations for managing hyperbilirubinemia in clinical settings. Statistical method The statistical analysis for this study will thoroughly examine the relationships between variables and derive meaningful insights from the collected data. SPSS Version 23 will be the tool of choice for conducting the analysis, employing various statistical methods tailored to the nature of the data. Descriptive statistics will present categorical variables in frequencies and percentages, such as the day of life and gestational age. Quantitative variables, including serum electrolyte levels and birth weight, will be described using measures of central tendency (mean or median) and dispersion (standard deviation or interquartile range). To compare serum electrolyte levels before and after phototherapy, paired t-tests or Wilcoxon signed-rank tests will be applied, depending on the data distribution. The chi-square test or Fisher’s exact test will be employed for comparing categorical variables, such as the presence or absence of specific conditions. Correlation analysis will use Pearson correlation or Spearman’s rank correlation to assess the strength and direction of relationships between continuous variables, particularly exploring correlations between electrolyte changes and the duration or intensity of phototherapy. Multivariate analysis will be conducted through multiple linear regression to explore the simultaneous impact of multiple independent variables, such as gestational age and birth weight, on the dependent variable, which could be changes in electrolyte levels. Subgroup analyses may investigate the influence of specific factors (e.g., gestational age, birth weight) on outcomes within distinct subpopulations. Sensitivity analyses may also be conducted to assess the robustness of the findings, evaluating the impact of potential outliers or variations in the analytical approach. Throughout the analysis, a significance level (alpha) of 0.05 will be considered, and p-values will be reported to determine the statistical significance of the findings. The research team will interpret the results in the context of the study objectives and relevant literature, providing a comprehensive understanding of the impact of phototherapy on electrolyte levels in newborns with hyperbilirubinemia. The chosen statistical methods aim to enhance the validity and reliability of the study’s conclusions. Ethical considerations The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2023/899. Date:31-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. Dissemination After the completion of the study, we will publish it in an indexed journal or conference. Study status The study is yet to start. After the publication of the protocol, we will start recruitment in the study. Discussion The proposed study aims to investigate the impact of phototherapy on electrolyte levels in newborns with hyperbilirubinemia, contributing valuable insights to understanding physiological changes associated with this common neonatal condition. The discussion will explore the potential implications of the study findings in the context of existing literature and clinical practice. The observed changes in serum electrolyte levels before and after phototherapy hold significance in managing hyperbilirubinemia. Previous studies have suggested that phototherapy may influence electrolyte balance in neonates, with reported alterations in sodium, potassium, and calcium levels. 5 , 6 The proposed study will add to this body of knowledge by providing specific insights into these electrolyte changes in the central Indian neonatal population. The correlation analysis between electrolyte changes and the duration/intensity of phototherapy is a crucial aspect of the study. It aligns with existing literature that underscores the importance of monitoring electrolyte levels during phototherapy. 7 The findings may guide clinicians in optimising phototherapy regimens, ensuring efficacy while minimising potential electrolyte disturbances in neonates. The exclusion criteria, including neonates with conjugated hyperbilirubinemia and those requiring intensive care, are aligned with previous studies that focused on uncomplicated hyperbilirubinemia. 8 , 9 However, the decision to exclude neonates with formula feeding and co-morbidities like acute renal failure warrants consideration in the context of potential variations in electrolyte response. Further research may be needed to explore these exclusions’ rationale and their impact on the generalizability of the study findings. The study’s strength lies in its rigorous methodology, including standardised data collection procedures and systematic control of confounding variables. However, the two-year duration may present challenges in maintaining consistency in data collection and potential changes in clinical practices over time. Regular data audits and periodic reassessment of protocols may mitigate these concerns. Ethics and consent The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2023/899. Date:31-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. Data availability No data are associated with this article. References 1. Ansong-Assoku B, Shah SD, Adnan M, et al. : Neonatal Jaundice. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. 2. Tan KL, Jacob E: Effect of phototherapy on neonatal fluid and electrolyte status. Acta Paediatr. Acad. Sci. Hung. 1981; 22 : 187–194. PubMed Abstract 3. Wang J, Guo G, Li A, et al. : Challenges of phototherapy for neonatal hyperbilirubinemia (Review). Exp. Ther. Med. 2021; 21 : 231. PubMed Abstract | Publisher Full Text | Free Full Text 4. Herin P, Aperia A: Neonatal kidney, fluids, and electrolytes. Curr. Opin. Pediatr. 1994; 6 : 154–157. Publisher Full Text 5. Alizadeh-Taheri P, Sajjadian N, Eivazzadeh B: Prevalence of Phototherapy Induced Hypocalcemia in Term Neonate. Iran. J. Pediatr. 2013; 23 : 710–711. PubMed Abstract 6. Khan M, Malik KA, Bai R: Hypocalcemia in jaundiced neonates receiving phototherapy. Pak. J. Med. Sci. 2016; 32 : 1449–1452. PubMed Abstract | Publisher Full Text | Free Full Text 7. Jafari Giv Z, Avan A, Hamidi F, et al. : Nutrients intake, and serum calcium and phosphorus levels: An evidence-based study. J. Clin. Lab. Anal. 2017; 32 : e22235. PubMed Abstract | Publisher Full Text | Free Full Text 8. Subcommittee on Hyperbilirubinemia: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics. 2004; 114 : 297–316. Publisher Full Text 9. Maisels MJ: Phototherapy--traditional and nontraditional. J. Perinatol. 2001; 21 Suppl 1 : S93–S97. discussion S104–S107. PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 09 May 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India Ankita Kiran Patel Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Jayant Vagha Roles: Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 09 May 2024, 13:469 https://doi.org/10.12688/f1000research.144931.1 Copyright © 2024 Kiran Patel A and Vagha J. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Kiran Patel A and Vagha J. An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.12688/f1000research.144931.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 09 May 2024 Views 0 Cite How to cite this report: Mallick AK. Reviewer Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r291762 ) The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-291762 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 03 Jul 2024 Asim Kumar Mallick , Nil RatanSircar Medical College & Hospital, Kolkata, India Approved VIEWS 0 https://doi.org/10.5256/f1000research.158801.r291762 “……..understanding of the physiological impact of Phototherapy”: Please elaborate on the significance of electrolyte imbalance following phototherapy in the Introduction Section. Mention the underlying mechanism, and how phototherapy leads to the disturbance in electrolyte level. ... Continue reading READ ALL “……..understanding of the physiological impact of Phototherapy”: Please elaborate on the significance of electrolyte imbalance following phototherapy in the Introduction Section. Mention the underlying mechanism, and how phototherapy leads to the disturbance in electrolyte level. Please explain how your research contributes to the existing body of knowledge as found in (Tosson A. et al., 2022[Ref 1]), (Purohit A, et al., 2020[Ref 2]) If the neonate has any genetic predisposition towards electrolyte imbalance, that shall be informed while collecting of the data. “The significance of this research lies in its potential to offer nuanced insights that may shape clinical practices, ultimately improving outcomes for neonates with hyperbilirubinemia undergoing phototherapy…..” Please elaborate the implication of the study and how it will benefit the clinicians. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. Impact of phototherapy type and duration on serum electrolytes and blood glucose in neonatal hyperbilirubinemia: a prospective single-center cohort study. https://epag.springeropen.com/articles/10.1186/s43054-022-00102-5 . 2022. Publisher Full Text 2. International Journal of Contemporary Pediatrics. https://www.ijpediatrics.com/index.php/ijcp/article/view/3519 . 2020. Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: NEONATAL HYPER BILIRUBINEMIA I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Mallick AK. Reviewer Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r291762 ) The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-291762 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Sahoo JP. Reviewer Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r277005 ) The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-277005 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 11 Jun 2024 Jagdish Prasad Sahoo , Neonatology, All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, Odisha, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.158801.r277005 1. What is the research question? 2. What phototherapy machine will be used? Is it CFL phototherapy or LED phototherapy? 3. What may be the possible reasons of electrolyte disturbance in a baby recieving phototherapy? If there is ... Continue reading READ ALL 1. What is the research question? 2. What phototherapy machine will be used? Is it CFL phototherapy or LED phototherapy? 3. What may be the possible reasons of electrolyte disturbance in a baby recieving phototherapy? If there is a plausible biological mechanism for the electrolyte disturbance? The CFL phototherapy used previously may cause some weight loss and electrolyte imbalance. But in the present time when, CFL phototherapy is completely replaced by LED phototherapy, which is also called as Cold light phototherapy because of non-generation of heat, why the researchers felt so to undertake the study? 4. The researchers need to explain the methos of Bilirubin, electrolyte estimation? 5. As the difficult sampling may falsely increase the potasium levels, how the researchers will ensure the sample collected is free flow sample to avoid spurious hyperkalemia? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Neonatology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sahoo JP. Reviewer Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r277005 ) The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-277005 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 09 May 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 09 May 24 read read Jagdish Prasad Sahoo , All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, India Asim Kumar Mallick , Nil RatanSircar Medical College & Hospital, Kolkata, India Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Mallick A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 03 Jul 2024 | for Version 1 Asim Kumar Mallick , Nil RatanSircar Medical College & Hospital, Kolkata, India 0 Views copyright © 2024 Mallick A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions “……..understanding of the physiological impact of Phototherapy”: Please elaborate on the significance of electrolyte imbalance following phototherapy in the Introduction Section. Mention the underlying mechanism, and how phototherapy leads to the disturbance in electrolyte level. Please explain how your research contributes to the existing body of knowledge as found in (Tosson A. et al., 2022[Ref 1]), (Purohit A, et al., 2020[Ref 2]) If the neonate has any genetic predisposition towards electrolyte imbalance, that shall be informed while collecting of the data. “The significance of this research lies in its potential to offer nuanced insights that may shape clinical practices, ultimately improving outcomes for neonates with hyperbilirubinemia undergoing phototherapy…..” Please elaborate the implication of the study and how it will benefit the clinicians. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. Impact of phototherapy type and duration on serum electrolytes and blood glucose in neonatal hyperbilirubinemia: a prospective single-center cohort study. https://epag.springeropen.com/articles/10.1186/s43054-022-00102-5 . 2022. Publisher Full Text 2. International Journal of Contemporary Pediatrics. https://www.ijpediatrics.com/index.php/ijcp/article/view/3519 . 2020. Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise NEONATAL HYPER BILIRUBINEMIA I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Mallick AK. Peer Review Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r291762) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-291762 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Sahoo J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 11 Jun 2024 | for Version 1 Jagdish Prasad Sahoo , Neonatology, All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, Odisha, India 0 Views copyright © 2024 Sahoo J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions 1. What is the research question? 2. What phototherapy machine will be used? Is it CFL phototherapy or LED phototherapy? 3. What may be the possible reasons of electrolyte disturbance in a baby recieving phototherapy? If there is a plausible biological mechanism for the electrolyte disturbance? The CFL phototherapy used previously may cause some weight loss and electrolyte imbalance. But in the present time when, CFL phototherapy is completely replaced by LED phototherapy, which is also called as Cold light phototherapy because of non-generation of heat, why the researchers felt so to undertake the study? 4. The researchers need to explain the methos of Bilirubin, electrolyte estimation? 5. As the difficult sampling may falsely increase the potasium levels, how the researchers will ensure the sample collected is free flow sample to avoid spurious hyperkalemia? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Neonatology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Sahoo JP. Peer Review Report For: An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2024, 13 :469 ( https://doi.org/10.5256/f1000research.158801.r277005) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-469/v1#referee-response-277005 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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