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NOT YET RECRUITING
NCT07901998

Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening accuracy. Second, researchers will compare the screening performance between the intelligent screening device and the optimized conventional manual screening, to preliminarily explore the value of this intelligent screening tool at high altitude. Finally, researchers will use descriptive qualitative research to deeply understand nurses' real-world experience, operational barriers and training needs when using the plainland two-indicator protocol, the optimized high-altitude two-indicator protocol, and the intelligent screening device in high-altitude settings. Echocardiography will be used as the reference gold standard.

Official title: Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease in High-Altitude Regions

Key Details

Gender

All

Age Range

6 Hours - 72 Hours

Study Type

OBSERVATIONAL

Enrollment

6300

Start Date

2026-10

Completion Date

2028-02

Last Updated

2026-10-28

Healthy Volunteers

Yes