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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrolysin®, neuroregeneration | Experimental | Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrolysin® | Drug | injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Side effects during cerebrolysin therapy (one course). | weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection. | 9 months |
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*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:
level of consciousness.
spontaneous activity.
posture.
tone.
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.
*Exclusion Criteria:
Severe intrauterine growth retardation.
Congenital malformations.
Suspected inborn error of metabolism.
Suspected inherited neurologic disease.
Intracranial hemorrhage
Meningitis
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| Name | Affiliation | Role |
|---|---|---|
| Sahar MA Hassanein, MD | Children's Hospital, Faculty of Medicine, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo | Cairo Governorate | 11381 | Egypt | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2019 | |
| Reset | May 9, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2019 | May 9, 2019 |
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C006952 | cerebrolysin |
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Children's Hospital, Faculty of Medicine, Ain Shams University |
| Cairo |
| 11381 |
| Egypt |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D001925 | Brain Damage, Chronic |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |