Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2025-12-17 @ 2:19 AM
Study NCT ID:
NCT06429007
Status:
None
Last Update Posted:
2025-11-25 00:00:00
First Post:
2024-05-07 00:00:00
Brief Title:
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
Sponsor:
Boston Childrens Hospital
Organization:
Boston Children's Hospital
Study Overview
Official Title:
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
Status:
None
Status Verified Date:
2025-11
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:
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None