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Genetic Study to Determine the Cause of Birth Defects in Newborns in Texas

NCT07102966 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2026-01-27

No results posted yet for this study

Summary

The purpose of this study is to provide advanced genetic testing and virtual consultations for seriously ill newborns in hospitals in Texas with fewer resources, especially along the Texas-Mexico border. The researchers also want to know how well the virtual consultation tool, called Consultagene, works in these hospitals by gathering feedback from healthcare providers. Researchers will provide rapid whole genome sequencing (WGS) to 200 infants over a period of 5 years. Data will be collected via Consultagene, surveys, and qualitative interviews.

Conditions

Interventions

GENETIC

Rapid whole genome sequencing

All consented patients will receive a virtual genetic evaluation and rapid whole genome sequencing

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Brendan Lee, MD, PhD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2029-03-31
Completion
2029-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102966 on ClinicalTrials.gov