Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-28 @ 12:18 PM
Study NCT ID:
NCT01059461
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2010-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Sponsor:
Sahar M.A. Hassanein, MD
Organization:
Study Overview
Official Title:
Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Status:
COMPLETED
Status Verified Date:
2013-09
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:
CerebroHIE
Brief Summary:
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
Detailed Description:
Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before , 3 and 6 months after therapy
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: