VIGOR: Virtual Genome Center for Infant Health
2 other identifiers
observational
750
1 country
10
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedStudy Start
First participant enrolled
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 3, 2026
January 1, 2026
4.7 years
January 5, 2022
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implementation of VIGOR
Penetration of VIGOR measured by percentage of eligible participants who were enrolled, tested, providers received CIR and completed a disclosure session.
4 year
Secondary Outcomes (6)
Implementation of VIGOR
4 year
Implementation of VIGOR
4 year
Service Outcomes
4 years
Client Outcomes
4 years
Client Outcomes
4 years
- +1 more secondary outcomes
Study Arms (2)
Neonates and Parents/Caregivers
Providers caring for newborns that meet eligibility criteria will approach parents to assess interest. The VIGOR study staff will remotely contact parents to complete consent for genomic sequencing (GS). We will also invite 1 additional primary caregiver (e.g. father, co-mother etc.) to participate even if that caregiver is not biologically related to the child. We will administer surveys at baseline enrollment to assess sociodemographics, obstetrical history, family genetic history \& mental health; within 1 week of disclosure of findings to assess satisfaction \& mental health; \& at 3 \& 6 months to further assess mental health \& newborn clinical outcomes. We will approach a subset of the families for qualitative interviews to assess satisfaction with VIGOR \& receipt of GS results with their physician in more detail.
Clinicians
Following focus groups at each of the participating sites to assess the feasibility \& needs of each site, the care teams will receive basic training in genomics and how to disclose GS results with VIGOR support. Study orientation will be completed as part of the training. Focus groups will be conducted within 1 year post implementation \& again between year 4 \& the completion of the study, to assess feasibility \& appropriateness of VIGOR. We will administer brief surveys to the care providers before \& after receipt of genomic education to assess their baseline knowledge \& comfort with genomic medicine in newborns. Surveys will be repeated within a week of disclosure to families regarding feedback on the process \& satisfaction with VIGOR. After approximately 3-5 disclosure events, study staff will approach the clinical care team members to participate in a qualitative interview to assess their perspectives in more depth.
Eligibility Criteria
The VIGOR center will enroll and follow for 12 months 250 eligible newborns and their families within community NICUs in the US serving diverse populations. Among enrolled newborns, rapid genomic sequencing will be facilitated along with the creation and return of timely Clinical Interpretive Reports to families and providers. This study comprehensively examine implementation outcomes according to a well-established framework at the NICU, provider, and newborn/caregiver-level.
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Boston Medical Centercollaborator
- Baystate Medical Centercollaborator
- UMass Memorial Healthcollaborator
- The Cooper Health Systemcollaborator
- National Human Genome Research Institute (NHGRI)collaborator
- DHR Health Institute for Research and Developmentcollaborator
- The Hospitals of Providence East Campuscollaborator
- The Hospitals of Providence Memorial Campuscollaborator
- Jackson Health Systemcollaborator
- University of Texascollaborator
- Driscoll Children's Hospitalcollaborator
- University of South Alabamacollaborator
Study Sites (10)
USA Children's and Women's Hospital
Mobile, Alabama, 36604, United States
Holtz Children's Hospital at Jackson Memorial Medical Center
Miami, Florida, 33136, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Hospital
Worcester, Massachusetts, 01605, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Driscoll Children's Hospital Rio Grande Valley
Edinburg, Texas, 78539, United States
The Women's Hospital at Renaissance
Edinburg, Texas, 78539, United States
The Hospitals of Providence
El Paso, Texas, 79938, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Related Publications (1)
D'Gama AM, Hills S, Douglas J, Young V, Genetti CA, Wojcik MH, Feldman HA, Yu TW, G Parker M, Agrawal PB; VIGOR Network. Implementation of rapid genomic sequencing in safety-net neonatal intensive care units: protocol for the VIrtual GenOme CenteR (VIGOR) proof-of-concept study. BMJ Open. 2024 Feb 6;14(2):e080529. doi: 10.1136/bmjopen-2023-080529.
PMID: 38320840DERIVED
Biospecimen
Genomic sequencing of neonates and biological parents will be performed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Yu, MD, PhD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 25, 2022
Study Start
March 22, 2022
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01