The HIEnome Study: Genome Sequencing for Perinatal HIE

This study, called The HIEnome Study, is looking at babies born with Hypoxic Ischemic Encephalopathy (HIE), a rare and serious condition where the brain doesn't get enough oxygen. Researchers want to see if genetic conditions play a role in HIE. If your baby is diagnosed with moderate or severe HIE, or HIE with seizures, and is undergoing total body cooling (therapeutic hypothermia) at Texas Children's Hospital, they might be able to join. The study involves genome sequencing (looking at your baby's complete set of DNA) and, if applicable, your DNA too. The main goal is to see how often a genetic cause for HIE is found by the time your child is 18 months old. The study is currently unclear on its recruitment status and plans to enroll 25 babies.

Study design
This is an interventional study involving 25 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will provide blood or buccal (cheek) samples during their hospital stay.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure diagnostic yield at 18 months.

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NCT06762795

The HIEnome Study: Genome Sequencing for Perinatal HIE

Recruiting
NAAges 0–1InterventionalDiagnostic
Baylor College of Medicine
~25 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:Genome sequencing

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic yield
Measured over 18 months
Hypoxic Ischemic Encephalopathy of Newborn
Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy (HIE)
2 sites across 1 states
Texas2

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Eligibility criteria

Inclusion

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

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)
  • Diagnostic yield18 months

    The primary outcome will be the number of cases with a pathogenic or likely-pathogenic variant associated with encephalopathy. This will further be stratified by the presence or absence of a perinatal hypoxic insult or sentinel event.