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

NCT ID: NCT01059461

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Hypoxic-Ischemic Encephalopathy

Keywords

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Hypoxic Ischemic Encephalopathy (HIE) Perinatal Asphyxia Nerve growth factor Cerebrolysin Cerebral palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cerebrolysin®, neuroregeneration

Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)

Group Type EXPERIMENTAL

Cerebrolysin®

Intervention Type DRUG

injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)

Interventions

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Cerebrolysin®

injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)

Intervention Type DRUG

Other Intervention Names

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Nerve Growth Factor

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahar M.A. Hassanein, MD

OTHER

Sponsor Role lead

Responsible Party

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Sahar M.A. Hassanein, MD

Professor of Pediatrics, Children's Hospital, Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sahar MA Hassanein, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Faculty of Medicine, Ain Shams University

Locations

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Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB 00006379

Identifier Type: -

Identifier Source: org_study_id