NCT05205356
VIGOR: Virtual Genome Center for Infant Health
Active, Not Recruiting
Not specifiedAges 0–99ObservationalBoston Children's HospitalInvestigator-initiated
~631 participants
Updated 2026-07-10 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implementation of VIGOR
Measured over 4 year
Conditions
Where it's being run
10 sites across 5 statesTexas4
Massachusetts3
Alabama1
Florida1
New Jersey1
Study leadership
- Timothy Yu, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Implementation of VIGOR4 year
Penetration of VIGOR measured by percentage of eligible participants who were enrolled, tested, providers received CIR and completed a disclosure session.