Status:

COMPLETED

South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

University of Mississippi Medical Center

HudsonAlpha Institute for Biotechnology

Conditions:

Whole Genome Sequencing

Eligibility:

All Genders

Phase:

NA

Brief 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...

Detailed Description

Barriers to widespread and routine implementation of WGS-enabled clinical care exist at several levels. Surveys of clinicians indicate discomfort in their understanding of genomics and ability to comm...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

April 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

477 Patients enrolled

Trial Details

Trial ID

NCT03842995

Start Date

April 15 2019

End Date

December 31 2023

Last Update

December 13 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Alabama at Birmingham/Children's of Alabama

Birmingham, Alabama, United States, 35294

2

Woman's Hospital

Baton Rouge, Louisiana, United States, 70895

3

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South | DecenTrialz