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: Completed NA study of Whole Genome Sequencing, sponsored by University of Alabama at Birmingham.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Collected after return of whole genome sequencing results using the GCOS. The GCOS is a 24-item counseling outcome scale to assess parental empowerment through questions addressing five constructs: Decision control, Cognitive control, Behavioral control, Emotional regulation, and Future orientation. Each of the 24-items is answered with a 7-point Likert-type scale: Strongly disagree (1), Disagree (2), Slightly disagree (3), Neither agree nor disagree (4), slightly agree (5), agree (6), and stron
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 |
What the finished NCT03842995 record still lists
NCT03842995 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Where NCT03842995's enrollment target sits among peer trials
477 219th of 2000 higher than 1,781 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03911700 · 477 participants · NA
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
- NCT06997497 · 477 participants · Phase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
- NCT05446272 · 478 participants · NA
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
- NCT06172296 · 478 participants · Phase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI