NCT07102966

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

MAGNET: Making Genomics Accessible For Newborns In Texas

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 90 Days
• Healthy volunteers: Accepted

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.

Detailed description

The study will use advanced testing such as WGS and RNA sequencing to look for possible diagnoses in infants. Only newborns with an unknown genetic diagnosis and admitted to a NICU in select Texas hospitals will be included. The researchers have executed broad reliance agreements with the participating NICUs in the study. Baylor IRB will serve as the IRB of record for all participating sites. All referrals will be received through Consultagene (www.consultagene.org). Baylor College of Medicine (BCM) will conduct virtual genetic evaluations using video visits, with help from the local hospital team. Photos and medical records will be reviewed, and blood or buccal swabs will be collected from the infants and parents. Test results will be returned in about a week, and researchers will provide genetic counseling to families through another virtual visit. If needed, additional testing will be done. Families will be connected to support groups, treatment options, and clinical trials if available. To understand the impact of the study, families will be asked to complete two short surveys; one at the beginning and one after they receive results. Doctors who use Consultagene will also be surveyed and interviewed to learn about their experience and gather feedback for improving the virtual tool. All data will be kept private and secure. DNA samples collected will be stored at BCM for future research, but without any identifying information. Samples may also be shared with other researchers studying similar health conditions, but only under strict guidelines.

Conditions

• Rare Diseases

Interventions

Type	Name	Description
GENETIC	Rapid whole genome sequencing	All consented patients will receive a virtual genetic evaluation and rapid whole genome sequencing

Timeline

• Start date: 2025-10-28
• Primary completion: 2029-03-31
• Completion: 2029-07-31
• First posted: 2025-08-05
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States