South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
Completed · Not applicable
Conditions studied: Whole Genome Sequencing
In brief
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.
Key facts
- Study ID
- NCT03842995
- Run by
- University of Alabama at Birmingham
- People needed
- 477
- Starts
- 2019-04-15
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2024-12-13
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Parents/caregiver/guardian of a newborn (proband) who meets the inclusion criteria in Specific Aim 1
- Parent or caregiver/guardian is willing to participate and answer surveys
You may not qualify if…
- Proband has secondary findings from WGS
- Parent or caregiver is not available to participate and answer surveys
- Parent or caregiver requires language interpreter services/translated materials
Where it is running
- University of Alabama at Birmingham/Children's of Alabama — Birmingham, Alabama, United States
- Woman's Hospital — Baton Rouge, Louisiana, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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