Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
Overview
- Phase
- Phase 2
- Intervention
- Cerebrolysin (Nerve growth factor)
- Conditions
- Cerebral Palsy Children
- Sponsor
- Ain Shams University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- neurodevelopment
- Last Updated
- 12 years ago
Overview
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.
Investigators
Sahar M.A. Hassanein, MD
Professor of Pediatrics
Ain Shams University
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.
Arms & Interventions
Cerebrolysin
Nerve growth factor Cerebrolysin will be given to the intervention group
Intervention: Cerebrolysin (Nerve growth factor)
Outcomes
Primary Outcomes
neurodevelopment
Time Frame: 6 months
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy