Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
| Registry | NCT02116348 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development |
| Interventions | Cerebrolysin (Nerve growth factor) (Drug) |
| Dates | start 2014-04-01, primary completion 2016-04-01 (estimated), completion 2016-04-01 (estimated), first posted 2014-04-16, last updated 2014-04-16 |
| Locations | 1 site in Egypt |
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All trials for Cerebral Palsy Children All trials for Children With Traumatic Brain Injury All trials of Cerebrolysin (Nerve growth factor)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cerebrolysin | Experimental | Drug: Cerebrolysin (Nerve growth factor) | Nerve growth factor Cerebrolysin will be given to the intervention group |
| Conventional | No intervention | These children will receive conventional treatment for cerebral palsy |
Sex: All, ages: 3 Months to 18 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo, Abassia | Egypt | Recruiting |