Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- neurodevelopment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy with mental retardation
- •Severe perinatal brain insult
排除标准
- •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.
研究组 & 干预措施
Cerebrolysin
Nerve growth factor Cerebrolysin will be given to the intervention group
干预措施: Cerebrolysin (Nerve growth factor) (Drug)
结局指标
主要结局
neurodevelopment
时间窗: 6 months
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy
次要结局
未报告次要终点
研究者
Sahar M.A. Hassanein, MD
Professor of Pediatrics
Ain Shams University