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Virtual genome center aims to close genetic care gap for newborns

NCT ID NCT05205356

Knowledge-focused Sponsor: Boston Children'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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study is testing a virtual genome center (VIGOR) to help sick newborns in community hospitals get genetic testing and expert advice without traveling to a big specialty center. The goal is to see if this approach works well and can be used more widely, especially for low-income and minority families. The study will enroll 750 newborns with suspected genetic conditions in the NICU and track how many families take part and how doctors use the results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show how to bring advanced genetic medicine to underserved communities, improving care for sick newborns.
What could go wrong
This is an early-stage implementation study, not testing a treatment. It may not lead to direct health improvements or be scalable.

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.

Participants

631 people

The number who actually took part.

Started

Mar 2022

Expected to finish

May 2027

An estimate. End dates often move.

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.

Who is studied

The VIGOR center will enroll and follow for 12 months 250 eligible newborns and their families within community NICUs in the US serving diverse populations. Among enrolled newborns, rapid genomic sequencing will be facilitated along with the creation and return of timely Clinical Interpretive Reports to families and providers. This study comprehensively examine implementation outcomes according to a well-established framework at the NICU, provider, and newborn/caregiver-level.

Ages

0 days to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Newborns presenting with probable genetic conditions inpatient on the NICU. These may include (but is not limited to) those with unexplained hypotonia, seizures, metabolic disorders, disorders of sex development, interstitial lung disease, immunodeficiency or multiple congenital anomalies. * Babies must have at least one biologic parent available for consent and participation. * The criteria for inclusion are 100% phenotype based and do not include any demographic parameters. Exclusion Criteria: * Presence of a likely nongenetic explanation for the phenotype (e.g., perinatal asphyxia explained by uterine rupture or placental pathology; * Clinical features pathognomonic for a recognizable chromosomal abnormality, such as trisomy 21; * Associations already known to have low genetic diagnostic yield, including VATER/VACTERL association and OEIS complex; * Infants who die before enrollment; * Known family history of genetic disease that is plausibly the cause of the infant's illness; - Those with a prenatal genetic diagnosis.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities 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 Genetics disease Genetics/birth defects

Contacts and locations

Locations

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Driscoll Children's Hospital Rio Grande Valley

    Edinburg, Texas, 78539, United States

  • Holtz Children's Hospital at Jackson Memorial Medical Center

    Miami, Florida, 33136, United States

  • The Hospitals of Providence

    El Paso, Texas, 79938, United States

  • The Women's Hospital at Renaissance

    Edinburg, Texas, 78539, United States

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01605, United States

  • USA Children's and Women's Hospital

    Mobile, Alabama, 36604, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

More trials for these conditions

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