Actively Recruiting

All Genders
Healthy Volunteers
ID07365254

Accurate Assessment and Intervention Research on Newborn Whole Genome Sequencing and Genetic Disease Risk (China Baby Omics)

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-01-26

1000000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Women's Hospital School Of Medicine Zhejiang University

Lead Sponsor

Z

Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Maternal and infant health is a key indicator of overall population health, facing new challenges due to rapid socioeconomic changes and environmental issues. This research focuses on understanding the causes of reproductive and pregnancy-related diseases, birth defects, and childhood illnesses by studying families from pregnancy through early life. The goal is to identify genetic, environmental, and behavioral risk factors that affect embryonic development, fetal health, and infant well-being. The project involves recruiting families expecting a child or with newborns and collecting biological samples such as blood, urine, and vaginal secretions at multiple points in time. These samples undergo multi-omics testing, including whole-genome sequencing, metabolite analysis, DNA methylation, protein expression, and microbiome sequencing. Data and clinical information are securely stored and carefully reviewed to ensure ethical, legal, and scientific standards. Participants will sign consent forms, complete questionnaires, and provide biological samples during the study. Researchers will analyze whole-genome sequencing and other molecular data about one year after sample collection to identify biomarkers and develop predictive models for reproductive and developmental diseases. The study includes long-term follow-ups on families to better understand early life risk factors and support prevention strategies for genetic diseases.

CONDITIONS

Brief Title

Accurate Assessment and Intervention Research on Newborn Whole Genome Sequencing and Genetic Disease Risk

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Families with ongoing pregnancies, conceived naturally or via assisted reproductive therapy
  • Newborn infants
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Varies based on sample collection schedule

Participants provide small amounts of biological samples such as peripheral blood, urine, and vaginal secretions within specified timeframes to support multi-omics experiments and analyses.

Multiple visits depending on sample collection schedule

Long-term Monitoring

Duration - Up to 1 year after completion of sample collection

Participants' clinical, gene, protein, metabolic, and microbiome-related data are stored and observed for research, ensuring compliance with ethical and legal standards.

No scheduled visits; data are collected from stored samples and records

Trial Site Locations

Total: 1 location

1

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

H

Hengchao Ruan, phD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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