Clinical Trial: Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
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 Summary: 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
Sponsor: Sahar M.A. Hassanein, MD
Current Primary Outcome: Side effects during cerebrolysin therapy (one course). [ Time Frame: 3 months ]
Original Primary Outcome:
- Survival until hospital discharge. [ Time Frame: 24 months ]
- Occurrence of severe side effects from the drug. [ Time Frame: 24 months ]
Current Secondary Outcome: Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection. [ Time Frame: 9 months ]
Original Secondary Outcome:
- Survival until 6 months of age. [ Time Frame: 18 months ]
- Improvement in neurological examination at 6, 12 and 18 months of age. [ Time Frame: 18 months ]
- MRI findings at 6 months of age. [ Time Frame: 18 months ]
Information By: Ain Shams University
Dates:
Date Received: January 29, 2010
Date Started: March 2011
Date Completion:
Last Updated: September 12, 2013
Last Verified: September 2013