AI for Newborn Metabolic Screening

Starting soon · Not applicable

Conditions studied: Inherited Metabolic Disorders

In brief

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

Key facts

Study ID

NCT07368504

Run by

The Children's Hospital of Zhejiang University School of Medicine

People needed

200000

Starts

2027-01-01

Expected to finish

2028-11-30

Last updated by the study team

2026-01-27

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Newborns who underwent routine newborn screening for inherited metabolic disorders at the Zhejiang Provincial Newborn Screening Center between May 2025 and December 2027
• Blood samples collected between 2 and 28 days of age
• Availability of complete newborn screening test data and essential clinical information

You may not qualify if…

• Missing, incomplete, or poor-quality screening data
• Duplicate samples from the same newborn

Where it is running

• The Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.