Early genetic screening for critical illnesses in newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a comprehensive program for early genetic screening of neonatal critical illnesses in China, focusing on hereditary diseases that contribute to neonatal mortality. Researchers will analyze genetic data from over 10,000 cases to identify the spectrum of genetic diseases affecting critically ill newborns. Utilizing advanced second-generation sequencing technology, a targeted gene panel of 300 genes will be developed for screening. The study will also implement an intelligent data analysis process that integrates clinical phenotypes with genetic information, collaborating with multiple hospitals for clinical validation of the findings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Postnatal age less than 100 days;
* Perinatal death after 20 weeks of gestation (more than 500 g)
* Can be retained biological samples for genetic screening;
* Biological parent or guardian's informed consent.

Exclusion Criteria:

* Reluctance of parents to use genetic sequencing data for subsequent research;
* Parents under 18 years of age or incapacitated for decision-making;
* subjects older than 100 days;
* Perinatal death less than 20 weeks of gestation or weight less than 500 g;
* Inherited metabolic diseases with chromosomal abnormalities;
* Multiple pregnancies;
* Lack of access to biological samples from which DNA can be extracted;
* Failure to sign informed consent.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wenhao Zhou
• Email: zhouwenhao@fudan.edu.cn
• Phone: +86-21-64931913

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.