At a glance
ClinicalIndex Comparison Record- ✓Parents/caregiver/guardian of a newborn (proband) willing to participate and answer surveys
- ✕Proband has secondary findings from WGS
- ✕Parent or caregiver not available to participate and answer surveys
- ✕Parent or caregiver requires language interpreter services or translated materials
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
South-seq: DNA Sequencing for Newborn Nurseries in the South
In Brief
A clinical study evaluating Genetic Counselor and Trained Healthcare Provider for Whole Genome Sequencing. Completed, enrolled 477 participants across 3 sites.
Detailed Summary
2,000 infants with signs suggestive of a genetic disorder being treated at a neonatal intensive care unit (NICU) in which African-American and rural populations are highly represented will be enrolled. Whole genome sequencing (WGS) will be used to identify pathogenic variation in DNA from these infants. Stakeholders, including parents, clinicians, and community leaders, will be engaged to develop culturally adapted educational materials and to equip non-genetics providers to return WGS results. Parents will be provided with these materials through a web portal, the Genome Gateway, and will be placed into one of two arms of a randomized trial to compare the effectiveness technology-assisted WGS result delivery by non-genetics providers relative to result delivery from genetic counselors.
Study Details
Timeline
Interventions
Standard of Care
Neonatologists and Neonatology Nurse Practitioners that receive training to deliver whole genome sequencing results