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Should all healthy newborns get their DNA screened? study investigates

NCT ID NCT05161169

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether whole genome sequencing can help screen healthy babies for genetic health risks. Researchers enrolled 500 infants and their parents from three U.S. cities, took a small blood sample from each baby, and sequenced the DNA of half the group. After three months, they shared the results with families and doctors to study the medical, emotional, and financial effects of this approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

500 people

The number who actually took part.

Started

Dec 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 12 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Infant participants * Has not previously had exome or genome sequencing * Age 0-12 months * Seen for well-baby pediatric care at a recruiting site * Primary healthcare provider completed the genomics education program * At least one parent or guardian able to participate in the study Parent participants * Biological parent or legal guardian of an infant participating in the study * 18 years of age or older * Unimpaired decision-making capacity * English or Spanish speaking * Available to have genetic counseling and provide consent for testing the infant Exclusion Criteria: * Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician * Any infant in which clinical considerations preclude collecting blood via heel stick

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Conditions

The condition(s) this trial relates to.

hereditary disease inherited disease susceptibility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genetic predisposition to disease Hereditary diseases

Contacts and locations

Locations

  • Beaumont - Corewell Health East

    Royal Oak, Michigan, 48073, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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Other studies related to the condition(s) this trial covers.