VIGOR: Virtual Genome Center for Infant Health

Running, not enrolling

Conditions studied: Genetics Disease, Genetics/Birth Defects, Genetic Predisposition to Disease

In brief

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.

Key facts

Study ID

NCT05205356

Run by

Boston Children's Hospital

People needed

631

Starts

2022-03-22

Expected to finish

2027-05-01

Last updated by the study team

2026-07-10

Who can join

Age: any, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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