Clinical trial Recruiting at 1 site Observational Ages Any age to 28 Days

Genetic testing of newborns in China

Official title: The China Neonatal Genomes Project

Run by Children's Hospital of Fudan University · NCT03931707 · Data updated 2026-11-12

This study is testing genetic testing on newborns in China to see if it can help identify inherited diseases early and improve treatment options for babies.

Quick facts

Study typeObservational
AgesAny age to 28 Days
SexAll
Enrollment100000 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedAugust 8, 2016
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedMarch 16, 2026
Trial IDNCT03931707 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this project are neonates of Chinese origin who are less than 28 days old and can provide a venous blood sample.

Probably not a fit

Patients who may not benefit include those whose parents are not of Chinese origin or those who are older than 28 days.

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

What this trial studies

The China Neonatal Genomes Project aims to conduct genetic testing on 100,000 neonates over five years to create a comprehensive neonatal genome database. This observational project focuses on identifying hereditary diseases and genetic predispositions in newborns, which can lead to early diagnosis and optimized treatment strategies. The initiative seeks to establish genetic testing standards for neonatal genetic diseases and enhance genetic counseling training. By analyzing medical histories, physical exams, and standard newborn screening reports, the project aims to improve the quality of life for affected children.

Why it matters

Potential benefit: If successful, this project could significantly enhance early diagnosis and treatment of genetic diseases in newborns, leading to better health outcomes.

How similar studies have gone: Other studies focusing on genetic testing in newborns have shown promise, indicating that this approach could be effective in improving early diagnosis and treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1\. Both parents are of Chinese origin;
* 2\. Postnatal age less than 28 days;
* 3\. Can be retained to at least 1ml venous blood sample;
* 4\. Biological parent or guardian's informed consent.

Exclusion Criteria:

* 1\. the nationality of one of the parents is not the Han nationality or other national minorities;
* 2\. reluctance of parents to use genetic sequencing data for subsequent research;
* 3\. parents under 18 years of age or incapacitated for decision-making;
* 4\. subjects older than 28 days.
* 5\. multiple pregnancies;
* 6\. lack of access to biological samples from which DNA can be extracted;
* 7\. failure to sign informed consent

Where it's running

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

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.