The HIEnome Study: Genome Sequencing for Perinatal HIE
Baylor College of Medicine
25 participants
May 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria2
- 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)
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Interventions
Neonates enrolled in this study will undergo genome sequencing with parental controls as applicable.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06762795