AI for Newborn Metabolic Screening

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based interpretation system can accurately diagnose inherited metabolic disorders in newborns undergoing routine screening. The main questions it aims to answer are: What is the sensitivity and specificity of the AI system compared to standard manual interpretation? Does the AI system reduce variability in screening results? Researchers will compare the AI interpretation results with those from standard manual review by trained laboratory staff to assess diagnostic performance. Participants will: Have their routine newborn screening blood samples analyzed using both the AI system and standard manual interpretation Be followed according to national newborn screening guidelines if either method indicates a positive result

NCT Number	NCT07368504
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine
Conditions	Inherited Metabolic Disorders
Enrollment	200,000 participants
Start Date	2027-01-01
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-27