Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2022-03-22
2027-03-01
Brief Summary
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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.
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Detailed Description
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This study will provide rigorous evaluation of implementing a virtual genome center at 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 minorities (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.
Conditions
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
0 Days
99 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Baystate Medical Center
OTHER
UMass Memorial Health
OTHER
The Cooper Health System
OTHER
National Human Genome Research Institute (NHGRI)
NIH
DHR Health Institute for Research and Development
OTHER
The Hospitals of Providence East Campus
UNKNOWN
The Hospitals of Providence Memorial Campus
UNKNOWN
Jackson Health System
OTHER
University of Texas
OTHER
Driscoll Children's Hospital
OTHER
University of South Alabama
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Timothy Yu
Associate Professor of Pediatrics
Principal Investigators
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Timothy Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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USA Children's and Women's Hospital
Mobile, Alabama, United States
Holtz Children's Hospital at Jackson Memorial Medical Center
Miami, Florida, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
UMass Memorial Hospital
Worcester, Massachusetts, United States
Cooper University Hospital
Camden, New Jersey, United States
Driscoll Children's Hospital Rio Grande Valley
Edinburg, Texas, United States
The Women's Hospital at Renaissance
Edinburg, Texas, United States
The Hospitals of Providence
El Paso, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Dynio Honrubia, MD
Role: primary
References
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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.
Other Identifiers
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IRB-P00040496
Identifier Type: -
Identifier Source: org_study_id
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