Cerebrolysin®
Druginjection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Other names: Nerve Growth Factor
NCT Number: NCT01059461
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.
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Notify Me3 month–6 month
All sexes
Interventional
Phase 2
Children's Hospital, Faculty of Medicine, Ain Shams University, Cairo, Cairo Governorate, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
*Inclusion Criteria: Infant aged 3-6 months with perinatal history of moderate or severe HIE collected from his NICU's file. Criteria of neonatal asphyxia and encephalopathy according to the American College of Obstetricians and Gynecologist and American Academy of Pediatrics, metabolic acidosis with a cord pH of 7.0 or less or a base deficit of at least 12 mmol/L, early onset of encephalopathy, and multisystem organ dysfunction with exclusion of other possible causes for findings.
Criteria of neonatal asphyxia:
Criteria of neonatal encephalopathy according to Sarnat and Sarnat. Presence of one or more signs in at least three of the following six categories:
*Exclusion Criteria:
injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Other names: Nerve Growth Factor
Time frame: 3 months
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
Time frame: 9 months
Sahar M.A. Hassanein, MD
Other
Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Acronym: CerebroHIE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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