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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital Show 9 more changesShow less
    • Primary completion date: Jun 30, 2025 to Apr 2027
    • Sponsor refiled this as active, not recruiting (was completed)
    • Enrollment target: 500 to 640
    • Study sites: 4 to 3
    • Study completion date: Jun 30, 2025 to Oct 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description revised
    • Collaborators: 12 to 10
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Feb 1, 2025 to Jun 30, 2025
    • Study completion date changed from estimate of Jul 1, 2025 to Jun 30, 2025
    • Site details revised at 4 of 4 sites
    v6
  4. Primary endpoints revised (6)
    • Secondary endpoints: 2 to 8
    v5
  5. Study sites: 3 to 4
    • Eligibility criteria shortened, about 13 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jul 1, 2021 to Dec 21, 2022v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2022 to Jul 1, 2021
    • Eligibility criteria shortened, about 26 words
    • Site details revised at 3 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05161169
Lead Sponsor Brigham and Women's Hospital
Collaborators: Baylor College of Medicine, Boston Children's Hospital, Broad Institute of MIT and Harvard, Harvard Pilgrim Health Care, HudsonAlpha Institute for Biotechnology, Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, University of Alabama at Birmingham, National Center for Advancing Translational Sciences (NCATS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Genetic Predisposition to Disease, Hereditary Diseases
Related terms Genetic Diseases, Inborn, Genetic Predisposition to Disease
Enrollment 640 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov