# Assessment of a Novel Newborn Screening Tool for Biliary Atresia

> **NIH NIH K23** · BAYLOR COLLEGE OF MEDICINE · 2020 · $179,591

## Abstract

PROJECT SUMMARY
This proposal is designed to prepare the candidate for an independent academic career in clinical and
translational research. The candidate’s long term goal is to discover innovative solutions for children with biliary
atresia and other liver diseases. The candidate has PhD training in basic science research, and he cares for
patients in a stimulating environment that exposes him to the full spectrum of pediatric liver disorders. Now the
candidate seeks formal training in clinical and translational research techniques, to allow him to synthesize
clinical observations and patient data and develop novel diagnostic, treatment, and prevention strategies.
The immediate goals of this project are threefold:
1) Acquire clinical and translational research skills through formal coursework, research experience, and
 mentor-guided instruction;
2) Develop ideas for future research, which can serve as the basis for a R03 or R01 grant application to
 initiate an independent career; and
3) Learn analytical, communication, and decision-making skills from an accomplished mentor, whose
 successful career path in pediatric hepatology will serve as a template.
To accomplish this, the candidate has created a rigorous career developmental plan to occur concurrently
while assessing a novel newborn screen for biliary atresia (BA). BA is a serious liver condition with significant
morbidity and mortality, and is the leading indication for pediatric liver transplantation in the US. If BA is
diagnosed and treated early, infants with disease can delay or even avoid need for liver transplantation;
however, infants are often diagnosed later because the disease is difficult to recognize in the first weeks of life.
Previously, the candidate observed that infants with BA have elevated direct or conjugated bilirubin levels at
birth, and proposed that this simple test could be used to screen newborns for disease.
The career development plan will equip the candidate with the necessary knowledge and skills to fully assess
newborn direct/conjugated bilirubin screening for BA. The candidate will learn how to conduct multi-center
studies and interpret large amounts of population data, by screening 102,000 newborns from 10 different birth
hospitals. The candidate will also take formal coursework to learn the theory and practice of cost-effective
studies, and then create sophisticated models simulating outcomes with and without screening which also
incorporate the screen’s associated costs. Finally, the candidate will learn specialized techniques in the clinical
chemistry laboratory and how to evaluate their utility, in the context of testing whether blood spot samples can
be used for the BA screening test.
At the conclusion of the training period, the candidate should be well trained to address complex problems in
pediatric hepatology at a clinical and translational research level. He should have many potential avenues of
further investigation, including characterizing the...

## Key facts

- **NIH application ID:** 9858324
- **Project number:** 5K23DK109207-04
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** SANJIV HARPAVAT
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $179,591
- **Award type:** 5
- **Project period:** 2017-02-16 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9858324

## Citation

> US National Institutes of Health, RePORTER application 9858324, Assessment of a Novel Newborn Screening Tool for Biliary Atresia (5K23DK109207-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9858324. Licensed CC0.

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