Abstract
Introduction and Aim
Delayed referral of neonatal cholestasis (NC) can result in significant morbidity and mortality. In this multi-center study, we aimed to evaluate the reliability of the stool card in the Indian population and develop an integrated NC card with (a) urine color identification and (b) stool color for early referral.
Methods
Consecutive children with NC were enrolled and divided into two groups (biliary atresia [BA] and non-BA). Normal healthy children at 6–8 weeks of age served as controls. Each photograph of stool and urine samples of every child was evaluated by 6 parents, 6 paramedical staff, and 4 trainee doctors using a stool color card as a reference for stool samples.
Results
Of 319 children (BA [n = 58], non-BA [n = 62], and controls [n = 199]), parents correctly detected dark yellow urine in all NC. Stool samples of 50 (86%) children with BA were unanimously labeled as pale by all observers. The average inter-item correlation showed good correlation between parents and trainee doctors of 0.77 and 0.64 with paramedical staff.
Conclusion
The integrated NC card proposes to recognize neonatal cholestasis at an early stage irrespective of etiology. It is a major step towards public health benefit both at the community as well as physicians’ levels to enable early detection and timely referral and management.
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Acknowledgments
We sincerely acknowledge “Health promotion administration, Department of Health and Family Welfare (HPA, DOHW), Taiwan” and Prof. Mei Wei Chang, Distinguished Chair Professor, Department of Pediatrics, National Taiwan University and Children Hospital, Taipei, Taiwan, for providing us permission to use Taiwan stool color card for our study.
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SK Yachha designed the study, analyzed the data, and revised the manuscript for important intellectual content. MC Das collected and analyzed the data and drafted the manuscript. P Kumar designed the study and revised the manuscript for important intellectual content. L Sharma collected the data and co-drafted the manuscript. SK Singh collected and analyzed the data and co-drafted the manuscript. M Sen Sarma supervised the study and revised the manuscript for important intellectual content. A Kumar performed the statistical analysis. A Srivastava and U Poddar supervised the study. All authors have read and approved the final version to be published.
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SKY, MCD, PK, LS, SKS, MSS, AK, AS, and UP declare that they have no conflict of interest.
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The study was performed conforming to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.
Institutional ethical clearance and parental consent were obtained from both the centers (center 1: IEC-2016-100-DM-91 and center 2:LHMC/ECHR/2016/41).
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Yachha, S.K., Das, M.C., Kumar, P. et al. Development of integrated neonatal cholestasis card for early recognition and referral of neonatal cholestasis. Indian J Gastroenterol 39, 584–590 (2020). https://doi.org/10.1007/s12664-020-01094-z
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DOI: https://doi.org/10.1007/s12664-020-01094-z