Study on Early Genetic Screening and Precise Strategy of Neonatal Critical Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 100
SponsorChildren's Hospital of Fudan University
About this trial
The researchers hope to establish an overall program of early genetic screening for neonatal critical illness in China, and to develop precise intervention strategies to assist clinical diagnosis and treatment of hereditary critical illness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
The subjects were all from all the member organizations participating in this research. They were hospitalized in the neonatal department or stillbirth in obstetrics department of each member hospital.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionIt's only observational study. No interventions.
Treatment groups
4,000 Participants
are divided into 1 treatment groupGroup A: Sick Neonates or Stillbirth1 intervention
Trial outcomes
Primary outcomes
1
Gene Mutation
To detect the mutation and characterize the genetic architecture and risk variants (911 variants of 146 genes, for example, AGT, AGTR1, CA12, CD2AP et al) of subjects using different genomic methods
Time frame
In 3 months after receipt of the samplesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
International Peace Maternity and Child Health Hospital
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Children's Medical Center
Collaborator
Shanghai Children's Hospital
Collaborator
Source ClinicalTrials.gov