Status:
RECRUITING
VIGOR: Virtual Genome Center for Infant Health
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Boston Medical Center
Baystate Medical Center
Conditions:
Genetics Disease
Genetics/Birth Defects
Eligibility:
All Genders
Up to 99 years
Brief 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...
Detailed Description
Genomic medicine has rapidly advanced in the past decade enabling earlier diagnosis and personalized treatment. However, only a few highly specialized centers in the US have the resources to take adva...
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.
- The criteria for inclusion are 100% phenotype based and do not include any demographic parameters.
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.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05205356
Start Date
March 22 2022
End Date
March 1 2027
Last Update
June 24 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
USA Children's and Women's Hospital
Mobile, Alabama, United States, 36604
2
Holtz Children's Hospital at Jackson Memorial Medical Center
Miami, Florida, United States, 33136
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Baystate Medical Center
Springfield, Massachusetts, United States, 01199