Rectal Ozone as Neuroprotector Post CNS Insult in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assessment of muscle Tone
研究概览
简要总结
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
详细描述
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually.
Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 1 month to 18 years.
- •Both sexes.
- •Children admitted to the pediatric intensive care unit (PICU) with acquired neurological insult.
- •Children with neurological sequelae
- •Children who are exposed to acquired brain injury, e.g., traumatic brain injury, cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, or hypoxia, with neurological sequelae diagnosed by neurological examination and magnetic resonance imaging (MRI), to detect that disorder early.
排除标准
- •Patients with no degree of disability or sequelae.
- •Patients not fit for Rectal ozone therapy.
- •Patients with active epilepsy and recurrent seizures.
- •Children with a positive family history of degenerative brain insults.
- •Children with behavioral problems.
研究组 & 干预措施
Group I
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
干预措施: Rectal ozone sessions (Other)
Group 2
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
干预措施: Conventional rehabilitation program (Other)
结局指标
主要结局
Assessment of muscle Tone
时间窗: 6 months post-sessions
Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity.
次要结局
- Incidence of reduction in neuroinflammation(6 months post-sessions)
- Assessment of quality of life(6 months post-sessions)
- Measurement of age-related response variability(6 months post-sessions)
- Incidence of adverse effects(6 months post-sessions)
研究者
Ahmed Mohamed Abd ELgawad Mohamed Asfour
Assistant Lecturer of Pediatrics, Faculty of Medicine, Al-Azhar University, Egypt.
Al-Azhar University