The HIEnome Study: Genome Sequencing for Perinatal HIE
Recruiting now · Not applicable
Conditions studied: Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
In brief
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.
Key facts
- Study ID
- NCT06762795
- Run by
- Baylor College of Medicine
- People needed
- 25
- Starts
- 2025-05-15
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-10-01
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Texas Children's Hospital — Houston, Texas, United States (enrolling)
- Texas Children's Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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