VIGOR: Virtual Genome Center for Infant Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-99
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
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.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
750 Participants
are grouped into 2 trial groupsGroup A: Neonates and Parents/Caregivers
Group B: Clinicians
Trial outcomes
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.
Time frame
4 yearSecondary outcomes
1
Implementation of VIGOR
Appropriateness of VIGOR measured at the provider level by conducting focus groups/interviews.
Time frame
4 year2
Implementation of VIGOR
Feasibility of VIGOR measured at the provider level by conducting focus groups/interviews.
Time frame
4 year3
Service Outcomes
Equity in penetration of VIGOR use by race/ethnicity, insurance status and primary language measured at the participant level by conducting chart reviews and surveys.
Time frame
4 years4
Client Outcomes
Function measured at the infant/caregiver and provider level by conducting surveys, chart reviews and focus groups/interviews.
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
Boston Medical Center
Collaborator
Baystate Medical Center
Collaborator
UMass Memorial Health
Collaborator
The Cooper Health System
Collaborator
National Human Genome Research Institute (NHGRI)
Collaborator
DHR Health Institute for Research and Development
Collaborator
The Hospitals of Providence East Campus
Collaborator
The Hospitals of Providence Memorial Campus
Collaborator
Jackson Health System
Collaborator
University of Texas
Collaborator
Driscoll Children's Hospital
Collaborator
University of South Alabama
Collaborator
Source ClinicalTrials.gov