Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03842995 · ClinicalTrials.gov registry record · NA
South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
A NA study of Whole Genome Sequencing, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 477
- Enrollment target
- 3
- Study locations
NCT03842995 is a NA study of Whole Genome Sequencing that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 477 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT03842995, a NA study of Whole Genome Sequencing, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 477 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Genetic Counselor
- BEHAVIORAL Trained Healthcare Provider
Study Locations (3)
Alabama
- University of Alabama at Birmingham/Children's of Alabama - Birmingham
Louisiana
- Woman's Hospital - Baton Rouge
Mississippi
- University of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03842995
The ClinicalTrials.gov registry entry for NCT03842995 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 477 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Whole Genome Sequencing appearing as the primary indexed condition, and to 2 interventions - of which Genetic Counselor is the first listed.
NCT03842995 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Louisiana, Mississippi.
Frequently Asked Questions
What is clinical trial NCT03842995 about?
NCT03842995 is a clinical study titled "South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South". 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 infa...
What is the current status of trial NCT03842995?
This trial is currently completed. It is a NA study. The enrollment target is 477 participants. The study started on 2019-04-15. Estimated completion is 2023-12-31.
What conditions does trial NCT03842995 study?
This clinical trial studies the following conditions: Whole Genome Sequencing.
What interventions are being tested in trial NCT03842995?
The interventions under investigation include: Genetic Counselor (BEHAVIORAL), Trained Healthcare Provider (BEHAVIORAL).
Who is sponsoring clinical trial NCT03842995?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03842995 being conducted?
This trial has 3 study locations across Alabama, Louisiana, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Whole Genome Sequencing
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.