NCT01059461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

January 29, 2010

Last Update Submit

September 12, 2013

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

Hypoxic Ischemic Encephalopathy (HIE)Perinatal AsphyxiaNerve growth factorCerebrolysinCerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Side effects during cerebrolysin therapy (one course).

    weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).

    3 months

Secondary Outcomes (1)

  • Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.

    9 months

Study Arms (1)

Cerebrolysin®, neuroregeneration

EXPERIMENTAL

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

Drug: Cerebrolysin®

Interventions

Cerebrolysin®DRUG

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

Also known as: Nerve Growth Factor
Cerebrolysin®, neuroregeneration

Eligibility Criteria

Age3 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe intrauterine growth retardation.
  • Congenital malformations.
  • Suspected inborn error of metabolism.
  • Suspected inherited neurologic disease.
  • Intracranial hemorrhage
  • Meningitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Cairo, Cairo Governorate, 11381, Egypt

Location

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

Cairo, 11381, Egypt

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainHereditary Sensory and Autonomic NeuropathiesCerebral Palsy

Interventions

cerebrolysinNerve Growth Factor

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsNervous System MalformationsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornBrain Damage, Chronic

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Officials

  • Sahar MA Hassanein, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics, Children's Hospital, Faculty of Medicine

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 1, 2010

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

EG(2)