Digital newborn screening for biliary atresia - Field study at the Charité – Universitätsmedizin Berlin

Digital newborn screening for biliary atresia - Field study at the Charité – Universitätsmedizin Berlin - DiaperID - Phase 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035304

Enrollment

500

Registered

2024-11-21

Start date

2024-11-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q44

Interventions

Group 1: The target population are liver-healthy newborns and infants with their guardians. The subject of the study is stool color analysis within the first five weeks of life for the early detection

participating parents are asked to upload at least one stool photo per week using the study app for digital stool colour analysis. The study ends with participation in an anonymous online questionnair

Eligibility

Sex/Gender

All

Age

No minimum to 5 Weeks

Inclusion criteria

Inclusion criteria: Healthy newborns

Exclusion criteria

Exclusion criteria: Liver diseases, longer hospital stay

Design outcomes

Primary

Measure	Time frame
User rate and adherence of parents to digital stool colour screening, measured by recruitment rates, usage rates, number of complete study participations. User satisfaction measured with PROM-based online questionnaires	—

Secondary

Measure	Time frame
Accuracy (sensitivity, specificity) of AI-based stool color analysis compared to blinded expert assessment by the study team, measured in %.	—

Countries

Germany

Contacts

Public ContactPhilip Bufler

Charité - Universitätsmedizin Berlin

philip.bufler@charite.de030-450616013

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026