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

Phase 2

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy
• Interventions: Drug: Cerebrolysin®

• Registration Number: NCT01059461
• Lead Sponsor: Sahar M.A. Hassanein, MD

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

Study Timeline

• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-01
• Study Start: 2011-03
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebrolysin®, neuroregeneration	Cerebrolysin®	Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)

Primary Outcome Measures

Name	Time	Method
Side effects during cerebrolysin therapy (one course).	3 months	weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.	9 months

Trial Locations

Locations (1)

Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt