Back to resultsStudy of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy (CerebroHIE)
Primary Purpose
Hypoxic-Ischemic Encephalopathy
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cerebrolysin®
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxic-Ischemic Encephalopathy focused on measuring Hypoxic Ischemic Encephalopathy (HIE), Perinatal Asphyxia, Nerve growth factor, Cerebrolysin, Cerebral palsy
Eligibility Criteria
*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.
- 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
Sites / Locations
- Children's Hospital, Faculty of Medicine, Ain Shams University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cerebrolysin®, neuroregeneration
Arm Description
Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Outcomes
Primary Outcome Measures
Side effects during cerebrolysin therapy (one course).
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
Secondary Outcome Measures
Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.
Full Information
NCT ID
NCT01059461
First Posted
January 29, 2010
Last Updated
September 12, 2013
Sponsor
Sahar M.A. Hassanein, MD
1. Study Identification
Unique Protocol Identification Number
NCT01059461
Brief Title
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Acronym
CerebroHIE
Official Title
Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sahar M.A. Hassanein, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy
Keywords
Hypoxic Ischemic Encephalopathy (HIE), Perinatal Asphyxia, Nerve growth factor, Cerebrolysin, Cerebral palsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerebrolysin®, neuroregeneration
Arm Type
Experimental
Arm Description
Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin®
Other Intervention Name(s)
Nerve Growth Factor
Intervention Description
injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Primary Outcome Measure Information:
Title
Side effects during cerebrolysin therapy (one course).
Description
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
*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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar MA Hassanein, MD
Organizational Affiliation
Children's Hospital, Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
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