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South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
NCT03842995 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03842995 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Alabama, Louisiana, Mississippi. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03842995?
The interventions under investigation include: Genetic Counselor (BEHAVIORAL), Trained Healthcare Provider (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03842995?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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