Clinical trial NCT01059461: Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Official title: Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: Hypoxic Ischemic Encephalopathy (HIE)
Perinatal Asphyxia
Nerve growth factor
Cerebrolysin
Cerebral palsy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Side effects during cerebrolysin therapy (one course).
timeFrame: 3 months
Secondary outcomes:
measure: Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Hospital, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Children's Hospital, Faculty of Medicine, Ain Shams University
name: Sahar MA Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
References: