Cerebral Palsy Children Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo | Abassia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | neurodevelopment | Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy | 6 months | No |
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