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 ]

weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).


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