Actively Recruiting

Age: 0Days - 99Years
All Genders
NCT05205356

VIGOR: Virtual Genome Center for Infant Health

Led by Boston Children's Hospital · Updated on 2026-02-03

750

Participants Needed

10

Research Sites

257 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

B

Boston Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities. The goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial/ethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers.

CONDITIONS

Official Title

VIGOR: Virtual Genome Center for Infant Health

Who Can Participate

Age: 0Days - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns admitted to NICU with probable genetic conditions such as unexplained hypotonia, seizures, metabolic disorders, sex development disorders, interstitial lung disease, immunodeficiency, or multiple congenital anomalies
  • At least one biological parent must be available to consent and participate
  • Inclusion is based entirely on the baby's symptoms and clinical features, not on demographics
Not Eligible

You will not qualify if you...

  • A likely non-genetic cause for the baby's symptoms (e.g., birth injury from uterine rupture or placental problems)
  • Clear clinical signs of known chromosomal disorders like trisomy 21 (Down syndrome)
  • Conditions with known low genetic diagnostic yield such as VATER/VACTERL association or OEIS complex
  • Infants who pass away before enrollment
  • Known family history of genetic disease likely causing the baby's illness
  • Babies with a prenatal genetic diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

USA Children's and Women's Hospital

Mobile, Alabama, United States, 36604

Actively Recruiting

2

Holtz Children's Hospital at Jackson Memorial Medical Center

Miami, Florida, United States, 33136

Actively Recruiting

3

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

4

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

5

UMass Memorial Hospital

Worcester, Massachusetts, United States, 01605

Actively Recruiting

6

Cooper University Hospital

Camden, New Jersey, United States, 08103

Actively Recruiting

7

Driscoll Children's Hospital Rio Grande Valley

Edinburg, Texas, United States, 78539

Actively Recruiting

8

The Women's Hospital at Renaissance

Edinburg, Texas, United States, 78539

Actively Recruiting

9

The Hospitals of Providence

El Paso, Texas, United States, 79938

Actively Recruiting

10

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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Research Team

T

Timothy Yu, MD, PhD

CONTACT

V

Vanessa J Young, MS, BA, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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