NCT06762795 The HIEnome Study: Genome Sequencing for Perinatal HIE
| NCT ID | NCT06762795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Hypoxic Ischemic Encephalopathy of Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-05-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury. Emerging evidence suggests that genetic conditions are frequently identified in cases of perinatal HIE; however, it is unclear which neonates with this diagnosis warrant genetic testing. This study will offer clinical genome sequencing to neonates with HIE who are undergoing total body cooling (therapeutic hypothermia) and their parents.
Eligibility Criteria
Inclusion Criteria: * Delivery ≥35w0d gestation * Diagnosed with moderate or severe HIE, or HIE with seizures * Undergoing total body cooling / therapeutic hypothermia * Able to provide blood or buccal samples during birth hospitalization * Admitted to Texas Children's Hospital Main, West, or Woodlands NICU Exclusion Criteria: * Parents/family not willing to allow participation * Inability to collect sufficient neonatal blood samples (in some circumstances, a buccal swab may be used as backup)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06762795 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 1 Year, studying Hypoxic Ischemic Encephalopathy of Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762795 currently recruiting?
Yes, NCT06762795 is actively recruiting participants. Contact the research team at christian.parobek@bcm.edu for enrollment information.
Where is the NCT06762795 trial being conducted?
This trial is being conducted at Houston, United States, Houston, United States.
Who is sponsoring the NCT06762795 clinical trial?
NCT06762795 is sponsored by Baylor College of Medicine. The trial plans to enroll 25 participants.