VIGOR: Virtual Genome Center for Infant Health

Launched by BOSTON CHILDREN'S HOSPITAL · Jan 19, 2022

Keywords

ClinConnect Summary

The VIGOR trial is studying how to improve access to advanced genetic medical care for sick newborns, particularly in community clinics that serve low-income families and racial or ethnic minorities. The goal is to create a virtual genome center that helps doctors and families understand genetic conditions better, consult with experts, and access the latest treatments. This approach aims to ensure that all babies, regardless of their background, can receive the best possible care for genetic issues.

To participate in this study, newborns in the Neonatal Intensive Care Unit (NICU) with possible genetic conditions—like unexplained muscle weakness or seizures—may be eligible, as long as at least one parent can provide consent. Unfortunately, infants with certain known genetic conditions or those who have died before enrolling cannot participate. Families involved can expect support and resources to help them navigate their baby's condition, as well as opportunities for education and consultation with genetics experts. This trial is currently recruiting participants and aims to make genetic healthcare more accessible for all families.

Gender

ALL

Eligibility criteria

• 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.