Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05161169
NA

Implementation of Whole Genome Sequencing as Screening in a Diverse Cohort of Healthy Infants

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

This research study is exploring the use of genomic sequencing in the newborn period to screen healthy babies for current and future health risks. The study will enroll a diverse cohort of over 500 healthy infants and their parents from Boston, MA; New York City, NY; Birmingham, AL; and additional U.S. cities. A small blood sample will be collected from each infant, and whole genome sequencing will be performed in 1/2 of the cohort following a randomized controlled trial design. 3 months later, the randomization status and sequencing results will be shared with parents and pediatricians. Investigators will study the medical, behavioral, and economic outcomes of genomic sequencing to better understand how this technology can be implemented in outpatient primary care settings.

Official title: Implementation of Whole Genome Sequencing as Screening in a Diverse Cohort of Healthy Infants (1U01TR003201-01A1)

Key Details

Gender

All

Age Range

0 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

640

Start Date

2022-12-21

Completion Date

2027-10

Last Updated

2026-10-02

Healthy Volunteers

Yes

Interventions

GENETIC

Genome Sequencing

20 times read depth (20x) next-generation whole genome sequencing with comprehensive analysis.

Locations (3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States