RecruitingNCT05205356

VIGOR: Virtual Genome Center for Infant Health


Sponsor

Boston Children's Hospital

Enrollment

750 participants

Start Date

Mar 22, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 DaysMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is about using genetic testing (genome sequencing) to help diagnose newborn babies in the NICU who appear to have a genetic condition. Doctors will sequence the DNA of the baby and at least one biological parent to try to find the cause of the baby's illness faster than traditional testing. You may be eligible if... - Your newborn is currently admitted to the NICU - Your baby has unexplained symptoms such as low muscle tone, seizures, metabolic problems, immune issues, or multiple birth defects - At least one biological parent is available to consent and participate You may NOT be eligible if... - There is a clear non-genetic explanation for your baby's condition (such as birth-related injury) - Your baby already shows obvious signs of a known chromosomal condition like Down syndrome - Your baby died before enrollment could happen - Your family already has a known genetic condition that likely explains the baby's illness - A genetic diagnosis was made before birth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(10)

USA Children's and Women's Hospital

Mobile, Alabama, United States

Holtz Children's Hospital at Jackson Memorial Medical Center

Miami, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

UMass Memorial Hospital

Worcester, Massachusetts, United States

Cooper University Hospital

Camden, New Jersey, United States

Driscoll Children's Hospital Rio Grande Valley

Edinburg, Texas, United States

The Women's Hospital at Renaissance

Edinburg, Texas, United States

The Hospitals of Providence

El Paso, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05205356


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