Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy (CerebroHIE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01059461
First received: January 29, 2010
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hypoxic-Ischemic Encephalopathy
Drug: Cerebrolysin®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Side effects during cerebrolysin therapy (one course). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cerebrolysin®, neuroregeneration
Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Drug: Cerebrolysin®
injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Other Name: Nerve Growth Factor

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

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059461

Locations
Egypt
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Egypt, 11381
Sponsors and Collaborators
Sahar M.A. Hassanein, MD
Investigators
Principal Investigator: Sahar MA Hassanein, MD Children's Hospital, Faculty of Medicine, Ain Shams University
  More Information

Additional Information:
No publications provided

Responsible Party: Sahar M.A. Hassanein, MD, Professor of Pediatrics, Children's Hospital, Faculty of Medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT01059461     History of Changes
Other Study ID Numbers: IRB 00006379
Study First Received: January 29, 2010
Last Updated: September 12, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Ain Shams University:
Hypoxic Ischemic Encephalopathy (HIE)
Perinatal Asphyxia
Nerve growth factor
Cerebrolysin
Cerebral palsy

Additional relevant MeSH terms:
Brain Ischemia
Ischemia
Brain Diseases
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hypoxia, Brain
Mitogens
Cerebrolysin
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Nootropic Agents

ClinicalTrials.gov processed this record on September 15, 2014