Development of integrated neonatal cholestasis card for early recognition and referral of neonatal cholestasis.

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.