Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Communication Function Classification System
研究概览
简要总结
This research aimed to investigate the effectiveness of hyperbaric oxygen therapy as a neuroprotective strategy for improving neurological outcomes in pediatric patients who have sustained acquired brain injury.
详细描述
Hyperbaric oxygen therapy (HBOT) is a medical treatment that delivers high-concentration oxygen in a pressurized chamber. It was developed initially from diving physiology research and popularized by Dutch surgeon Boerema for its life-sustaining plasma oxygen diffusion under hyperbaric conditions.
The fundamental mechanism of HBOT operates through Henry's Law, enabling unprecedented increases in tissue oxygen partial pressures that surpass levels achievable in normal atmospheric conditions.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 4-12 years with acquired brain injury.
- •Confirmed neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, hypoxia) via MRI/neurological exam.
排除标准
- •Positive family history of degenerative brain insults.
- •Behavioral problems.
- •Hyperbaric oxygen therapy contraindications:
- •Active epilepsy.
- •Respiratory insufficiency.
- •Uncontrolled heart failure.
- •Eustachian tube dysfunction.
- •Tympanic membrane rupture.
- •Mechanical ventilation dependency.
研究组 & 干预措施
Control group
Patients received conventional rehabilitation alone.
干预措施: Conventional rehabilitation (Other)
Hyperbaric oxygen therapy group
Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
干预措施: Hyperbaric oxygen therapy (Other)
结局指标
主要结局
Communication Function Classification System
时间窗: Eight months post-intervention
The Communication Function Classification System (CFCS) was implemented to assess cognitive and speech capabilities across five levels of communicative competence. * Level I: Effective bidirectional communication (no need for external aids). * Level II: Consistent communication with familiar partners, occasional need for aids. * Level III: Communication requires significant effort and aids with familiar partners. * Level IV: Minimal communication, even with familiar partners. * Level V: No effective communication.
次要结局
- Nutritional intake functionality(Eight months post-intervention)
- Visual function assessment(Eight months post-intervention)
研究者
Eman Mohammed Abdel Hamid Gaml
Assistant Lecturer of Pediatrics, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.
Kafrelsheikh University