Gene tests for sick newborns: a lifesaver in the NICU?

NCT ID NCT02551081

Recruiting now Knowledge-focused Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether using rapid genetic sequencing can help doctors diagnose and treat birth defects in newborns in intensive care. Researchers will enroll 2,000 babies and compare death rates, disability rates, and genetic findings. The goal is to see if personalized treatment based on genetics improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Next Generation Sequencing (genetic testing)
What this could lead to: If successful, this could show that rapid genetic testing helps doctors diagnose and treat birth defects faster, potentially improving survival and development for newborns.
What could go wrong: This is an observational study, not a treatment trial. It may not directly improve outcomes, and the benefits of faster diagnosis are still unproven.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities developmental defect during embryogenesis hereditary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL MALFORMATION GENETIC DISEASE MULTIPLE MALFORMATION

Contacts and locations

Locations

Children Hospital of Fudan University
RECRUITING

Shanghai, Shanghai Municipality, China

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