Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-29 @ 1:15 PM
Study NCT ID:
NCT06762795
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The HIEnome Study: Genome Sequencing for Perinatal HIE
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
The HIEnome Study: Genome Sequencing for Perinatal HIE
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: