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The HIEnome Study: Genome Sequencing for Perinatal HIE

NCT06762795 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

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

Interventions

GENETIC

Genome sequencing

Neonates enrolled in this study will undergo genome sequencing with parental controls as applicable.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762795 on ClinicalTrials.gov