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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-05-09', 'releaseDate': '2019-02-09'}], 'estimatedResultsFirstSubmitDate': '2019-02-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C006952', 'term': 'cerebrolysin'}, {'id': 'D020932', 'term': 'Nerve Growth Factor'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-01-29', 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side effects during cerebrolysin therapy (one course).', 'timeFrame': '3 months', 'description': "weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections)."}], 'secondaryOutcomes': [{'measure': 'Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypoxic Ischemic Encephalopathy (HIE)', 'Perinatal Asphyxia', 'Nerve growth factor', 'Cerebrolysin', 'Cerebral palsy'], 'conditions': ['Hypoxic-Ischemic Encephalopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "\\*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.\n\nCriteria of neonatal asphyxia:\n\n* Full term neonate more than 36 weeks of gestation\n* 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.\n* 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.\n\nCriteria of neonatal encephalopathy according to Sarnat and Sarnat. Presence of one or more signs in at least three of the following six categories:\n\n* level of consciousness.\n* spontaneous activity.\n* posture.\n* tone.\n* primitive reflexes (suck or Moro.\n* 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.\n\n \\*Exclusion Criteria:\n* Severe intrauterine growth retardation.\n* Congenital malformations.\n* Suspected inborn error of metabolism.\n* Suspected inherited neurologic disease.\n* Intracranial hemorrhage\n* Meningitis"}, 'identificationModule': {'nctId': 'NCT01059461', 'acronym': 'CerebroHIE', 'briefTitle': 'Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy', 'orgStudyIdInfo': {'id': 'IRB 00006379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerebrolysin®, neuroregeneration', 'description': 'Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)', 'interventionNames': ['Drug: Cerebrolysin®']}], 'interventions': [{'name': 'Cerebrolysin®', 'type': 'DRUG', 'otherNames': ['Nerve Growth Factor'], 'description': 'injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)', 'armGroupLabels': ['Cerebrolysin®, neuroregeneration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11381', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': "Children's Hospital, Faculty of Medicine, Ain Shams University", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11381', 'city': 'Cairo', 'country': 'Egypt', 'facility': "Children's Hospital, Faculty of Medicine, Ain Shams University", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sahar MA Hassanein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital, Faculty of Medicine, Ain Shams University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahar M.A. Hassanein, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Professor of Pediatrics, Children's Hospital, Faculty of Medicine", 'investigatorFullName': 'Sahar M.A. Hassanein, MD', 'investigatorAffiliation': 'Ain Shams University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-02-09', 'type': 'RELEASE'}, {'date': '2019-05-09', 'type': 'RESET'}], 'unpostedResponsibleParty': "Sahar M.A. Hassanein, MD, Professor of Pediatrics, Children's Hospital, Faculty of Medicine, Ain Shams University"}}}}