Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy (CerebroHIE)
This study has been completed.
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
First received: January 29, 2010
Last updated: September 12, 2013
Last verified: September 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Primary Outcome Measures:
Secondary Outcome Measures:
- Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Experimental: Cerebrolysin®, neuroregeneration
Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Other Name: Nerve Growth Factor
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
|Ages Eligible for Study:
||3 Months to 6 Months
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
*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:
- Full term neonate more than 36 weeks of gestation
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
- If, during this interval, a pH is between 7.01 and 7.15, a base deficit is between 10 and 15.9 mmol per liter, or a blood gas is not available, additional criteria are required. These includes an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiates at birth and continues for at least 10 minutes.
Criteria of neonatal encephalopathy according to Sarnat and Sarnat. Presence of one or more signs in at least three of the following six categories:
- level of consciousness.
- spontaneous activity.
- primitive reflexes (suck or Moro.
autonomic nervous system (pupils, heart rate, or respiration). The number of moderate or severe signs determined the extent of encephalopathy; if signs were equally distributed, the designation was based on the level of consciousness.
- Severe intrauterine growth retardation.
- Congenital malformations.
- Suspected inborn error of metabolism.
- Suspected inherited neurologic disease.
- Intracranial hemorrhage
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059461
|Children's Hospital, Faculty of Medicine, Ain Shams University
|Cairo, Egypt, 11381 |
Sahar M.A. Hassanein, MD
||Sahar MA Hassanein, MD
||Children's Hospital, Faculty of Medicine, Ain Shams University
No publications provided
||Sahar M.A. Hassanein, MD, Professor of Pediatrics, Children's Hospital, Faculty of Medicine, Ain Shams University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 29, 2010
||September 12, 2013
||Austria: Agency for Health and Food Safety
Keywords provided by Ain Shams University:
Hypoxic Ischemic Encephalopathy (HIE)
Nerve growth factor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Brain Damage, Chronic
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Central Nervous System Viral Diseases
Central Nervous System Infections
Digestive System Diseases
Brain Diseases, Metabolic