Actively Recruiting

Phase Not Applicable
Age: 0Days - 1Year
All Genders
NCT06762795

The HIEnome Study: Genome Sequencing for Perinatal HIE

Led by Baylor College of Medicine · Updated on 2025-10-01

25

Participants Needed

2

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The HIEnome Study: Genome Sequencing for Perinatal HIE

Who Can Participate

Age: 0Days - 1Year
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Delivery at 35 weeks 0 days gestation or later
  • Diagnosed with moderate or severe hypoxic-ischemic encephalopathy (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 neonatal intensive care units
Not Eligible

You will not qualify if you...

  • Parents or family not willing to allow participation
  • Inability to collect sufficient neonatal blood samples (buccal swab may be used as a backup in some cases)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

2

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Christian Parobek, MD, PhD

CONTACT

S

Seema Lalani, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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