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RECRUITING Not applicable ClinicalTrials.gov

The HIEnome Study: Genome Sequencing for Perinatal HIE

Sponsor: Baylor College of Medicine • ClinicalTrials.gov ID: NCT06762795

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Genome sequencing (Genetic)
    Neonates enrolled in this study will undergo genome sequencing with parental controls as applicable.

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)

Conditions

Hypoxic Ischemic Encephalopathy of Newborn Hypoxic Ischemic Encephalopathy Hypoxic Ischemic Encephalopathy (HIE)

Locations

  • Texas Children's Hospital — Houston, Texas, United States
  • Texas Children's Hospital — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record