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Newborn screening for biliary atresia using direct bilirubin: An implementation science study
1Lucile Salter Packard Children's Hospital at Stanford, Palo Alto, CA, USA.
Insights
Early detection of biliary atresia (BA) is crucial. A two-stage direct bilirubin (DB) screening strategy in newborns significantly reduced the average age at Kasai portoenterostomy, improving infant outcomes.
Area of Science:
- Neonatal Medicine
- Pediatric Gastroenterology
- Public Health Screening
Background:
- Biliary atresia (BA) is a severe infant liver disease requiring early intervention.
- Optimal outcomes for BA depend on Kasai portoenterostomy before 45 days of life (DoL).
- Late presentation in our system averaged 60 DoL, necessitating improved screening.
Purpose of the Study:
- To implement and evaluate a two-stage direct bilirubin (DB) screening strategy for early BA detection.
- To reduce the average age at diagnosis and treatment for infants with BA.
Main Methods:
- Newborns screened for DB at 24-48 hours of life.
- Infants with DB ≥0.5 mg/dL underwent repeat testing at 2 weeks.
- DB ≥1.0 mg/dL prompted gastroenterology evaluation.
Main Results:
- 99.5% of 3880 infants were screened; 1.3% initially had DB ≥0.5 mg/dL.
- 12 infants (0.3% false positive rate) had repeat DB ≥1.0 mg/dL, prompting evaluation.
- Average time to gastroenterology evaluation was 18.3 DoL, with BA excluded by 28 DoL.
Conclusions:
- The two-stage DB screening protocol effectively identifies infants needing further evaluation for BA.
- This strategy significantly shortens the diagnostic and treatment timeline compared to previous practices.
- The protocol offers a replicable model for other institutions to improve BA detection rates.
Abstract:
ObjectiveBiliary atresia (BA) is a liver disease of infancy characterized by obstruction of the biliary tree. Infants with BA have the best outcomes when identified early and the Kasai portoenterostomy is performed before 45 days of life (DoL). In our hospital system, the average age at Kasai was 60 DoL. To address the problem of late presentation, we implemented a two-stage BA screening strategy utilizing direct bilirubin (DB).MethodsNew institutional policies were established that all newborns were tested at 24-48 h of life, and those with levels ≥0.5 mg/dL were followed further. The infant's primary care provider was contacted to recommend a repeat DB at 2 weeks of life. If the repeat DB was ≥1.0 mg/dL, the patient was evaluated by gastroenterology.ResultsOver the 16 months, 3880 infants were born and 3861 (99.5%) were screened; 53 infants (1.3%) had DB levels ≥0.5 mg/dL initially. Upon repeat testing at 2 weeks, there were three groups of infants: not retested (n = 1), retested <1.0 mg/dL (n = 40), and retested ≥1.0 mg/dL (n = 12). The average time to be seen by gastroenterology was 4.3 days or 18.3 DoL.DiscussionThe screening included a series of steps that needed to be implemented effectively. Screening had a net false positive rate of 0.3% (12 out of 3861) and identified causes of cholestasis other than BA. BA was excluded by 28 DoL on average. Our results can provide a template for other institutions interested in implementing a BA screening protocol in their practice.
