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

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ClinicalTrials.gov Identifier: NCT01059461
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Drug: Cerebrolysin® Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Study Start Date : March 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Side effects during cerebrolysin therapy (one course). [ Time Frame: 3 months ]
    weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).


Secondary Outcome Measures :
  1. Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection. [ Time Frame: 9 months ]


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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Sahar M.A. Hassanein, MD, Ain Shams University:
Hypoxic Ischemic Encephalopathy (HIE)
Perinatal Asphyxia
Nerve growth factor
Cerebrolysin
Cerebral palsy

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