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Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

Primary Purpose

Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cerebrolysin (Nerve growth factor)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Children focused on measuring Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cerebral palsy with mental retardation
  • Severe perinatal brain insult

Exclusion Criteria:

  1. Severe growth retardation
  2. Gastrostomy tube feeding
  3. Intractable seizures.
  4. Severe motor handicap and deformities from long standing spasticity.
  5. Congenital malformations.
  6. Suspected inborn error of metabolism.
  7. Suspected inherited neurologic disease.
  8. Children with auditory and visual impairments.
  9. Care giver's refusal to participate in the study.

Sites / Locations

  • Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cerebrolysin

Conventional

Arm Description

Nerve growth factor Cerebrolysin will be given to the intervention group

These children will receive conventional treatment for cerebral palsy

Outcomes

Primary Outcome Measures

neurodevelopment
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy

Secondary Outcome Measures

Full Information

First Posted
April 15, 2014
Last Updated
April 15, 2014
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02116348
Brief Title
Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy
Official Title
Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden. Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development
Keywords
Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Description
Nerve growth factor Cerebrolysin will be given to the intervention group
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
These children will receive conventional treatment for cerebral palsy
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin (Nerve growth factor)
Other Intervention Name(s)
Cerebrolysin
Intervention Description
Cerebrolysin will be given to the intervention group
Primary Outcome Measure Information:
Title
neurodevelopment
Description
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral palsy with mental retardation Severe perinatal brain insult Exclusion Criteria: Severe growth retardation Gastrostomy tube feeding Intractable seizures. Severe motor handicap and deformities from long standing spasticity. Congenital malformations. Suspected inborn error of metabolism. Suspected inherited neurologic disease. Children with auditory and visual impairments. Care giver's refusal to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar M.A. Hassanein, MD
Phone
201223183943
Email
saharhassanein@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar M.A. Hassanein, MD, PhD
Organizational Affiliation
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
State/Province
Abassia
ZIP/Postal Code
11381
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen S Elalfy, MD, PhD
Email
elalfym@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tarek A. Abdo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Neveen T. Younis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Iman AA Elagouza, MD, PhD
First Name & Middle Initial & Last Name & Degree
Shaymaa A Maher, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eman A.M. Medany, M.SC

12. IPD Sharing Statement

Links:
URL
http://med.asu.edu.eg/
Description
Faculty of Medicine, Ain Shams University
URL
http://www.asu.edu.eg/
Description
Ain Shams University web site

Learn more about this trial

Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

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