RecruitingNCT03931707

The China Neonatal Genomes Project


Sponsor

Children's Hospital of Fudan University

Enrollment

100,000 participants

Start Date

Aug 8, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

The project will carry out the genetic testing of 100000 neonates in the next 5 years. The aim of the project is to construct the Chinese neonatal genome database, establish the genetic testing standard of neonatal genetic diseases, and promote the industrialization of neonatal genetic disease gene testing, improve the training system for genetic counseling.


Eligibility

Max Age: 28 Days

Inclusion Criteria4

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

Exclusion Criteria7

  • \. the nationality of one of the parents is not the Han nationality or other national minorities;
  • \. 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 28 days.
  • \. multiple pregnancies;
  • \. lack of access to biological samples from which DNA can be extracted;
  • \. failure to sign informed consent

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Interventions

GENETICGenomic sequencing

Both sick and high-risk newborn un-randomized to receive genomic sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.


Locations(1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT03931707


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