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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT07102966
Status
Recruiting
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Conditions

  • Rare Diseases

Eligibility Criteria

Sex
ALL
Age
1 Day - 90 Days
Healthy Volunteers
Accepted

Interventions

  • Rapid whole genome sequencing — GENETIC
    All consented patients will receive a virtual genetic evaluation and rapid whole genome sequencing

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
410 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: MAGNET study patients
    Patients receiving rapid whole genome sequencing

Primary Outcome Measure

Effectiveness of Consultagene [ Time Frame: From enrollment to the end of treatment-4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Seema Lalani, MD
[email protected]
281-224-0600

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By research site
Baylor College of Medicine· Houston, TX

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