The China Neonatal Genomes Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorChildren's Hospital of Fudan University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The subjects were all from all the member organizations participating in the China Newborn Genome Project. They were hospitalized in the neonatal department of each member hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Genomic sequencing
GeneticBoth 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.
Treatment groups
100,000 Participants
are divided into 1 treatment groupGroup A: Sick Neonatal Cohort, Sequencing1 intervention
Trial outcomes
Primary outcomes
1
Number of gene sequencing data in neonatal gene bank
Each newborn that was sequenced was counted as 1. Keep all the data in the gene bank, and finally calculate the number of completed gene sequencing data.
Time frame
From birth to completion of genetic screening, the process last up to 3 months.2
Gene mutation rate
Taking the number of newborn babies as denominator and the number of neonates with gene mutation detected in gene sequencing as molecules, the whole neonatal gene mutation rate in China was obtained.
Time frame
From birth to completion of genetic screening, the process last up to 3 months.Sponsors and contacts
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Source ClinicalTrials.gov