Genome sequencing for newborns with perinatal hypoxic‑ischemic encephalopathy
Official title: The HIEnome Study: Genome Sequencing for Perinatal HIE
Run by Baylor College of Medicine · NCT06762795 · Data updated 2026-11-12
This program will try genome sequencing for newborns with moderate-to-severe hypoxic‑ischemic encephalopathy who are receiving therapeutic cooling, using parent samples to help interpret results.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 1 Year |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT06762795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newborns ≥35 weeks' gestation with moderate or severe HIE (or HIE with seizures) who are undergoing therapeutic hypothermia in one of Texas Children's Hospital NICUs and can provide neonatal and parental samples.
✕Probably not a fit
Babies with mild HIE, those born before 35 weeks, infants not receiving therapeutic cooling, patients admitted outside Texas Children's Hospital, or cases where sufficient samples cannot be obtained are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The HIEnome protocol offers clinical whole-genome sequencing to neonates diagnosed with moderate or severe perinatal HIE (including HIE with seizures) who are undergoing total body cooling, and to their parents for trio analysis. Eligible infants are ≥35 weeks' gestation, admitted to Texas Children's Hospital NICUs, and able to provide blood or buccal samples during the birth hospitalization. Sequencing and interpretation are performed as a clinical service to identify genetic conditions that may explain the encephalopathy or influence care. The project aims to clarify which neonates with perinatal HIE carry genetic diagnoses and to improve diagnostic pathways and counseling.
Why it matters
Potential benefit: If successful, this could identify underlying genetic causes that improve prognosis, guide medical care, and support family counseling.
How similar studies have gone: Previous research has begun to show that genetic diagnoses are often found in neonatal encephalopathy cases, but the approach is still emerging and not yet standardized.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Texas Children's Hospital
Houston, Texas, United States Recruiting -
Texas Children's Hospital
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Christian Parobek, MD, PhD
- Email: christian.parobek@bcm.edu
- Phone: 828-713-9962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.