Virtual Genome Center for Infant Health
VIGOR: Virtual Genome Center for Infant Health
This study is testing a virtual program to help sick newborns with possible genetic disorders get better access to expert care and support, especially in communities that need it most.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 0 Days to 99 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 10 sites (Mobile, Alabama and 9 other locations) |
| Trial ID | NCT05205356 on ClinicalTrials.gov |
What this trial studies
This initiative aims to implement a virtual genome center to enhance access to genomic medicine for sick newborns in community settings, particularly those serving low-income and underrepresented minority populations. By providing education, expert consultation, and reanalysis of genetic data, the program seeks to bridge the gap in healthcare disparities related to genetic conditions. The focus is on newborns in the NICU with probable genetic disorders, ensuring equitable access to advanced medical care. The study will evaluate the effectiveness of this model in improving healthcare delivery and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns in the NICU presenting with probable genetic conditions, along with at least one biologic parent available for consent.
Not a fit: Patients who may not benefit from this study include those with a likely non-genetic explanation for their condition or known chromosomal abnormalities.
Why it matters
Potential benefit: If successful, this initiative could significantly improve access to genomic medical care for vulnerable populations, leading to better health outcomes for sick newborns.
How similar studies have performed: While the approach of implementing a virtual genome center is innovative, similar studies have shown promise in addressing healthcare disparities through telemedicine and remote consultations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mobile, Alabama and 9 other locations
- USA Children's and Women's Hospital — Mobile, Alabama, United States (Recruiting)
- Holtz Children's Hospital at Jackson Memorial Medical Center — Miami, Florida, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- Baystate Medical Center — Springfield, Massachusetts, United States (Recruiting)
- UMass Memorial Hospital — Worcester, Massachusetts, United States (Recruiting)
- Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
- Driscoll Children's Hospital Rio Grande Valley — Edinburg, Texas, United States (Recruiting)
- The Women's Hospital at Renaissance — Edinburg, Texas, United States (Recruiting)
- The Hospitals of Providence — El Paso, Texas, United States (Recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Yu, MD, PhD — Boston Children's Hospital
- Study coordinator: Timothy Yu, MD, PhD
- Email: timothy.yu@childrens.harvard.edu
- Phone: 617-919-7499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.