Treating Brain Swelling in Pediatric Cerebral Malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants Who Died
研究概览
简要总结
This study evaluates the effectiveness of two interventions in Malawian children with cerebral malaria at high risk of death. One-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.
详细描述
An important mechanism of death in children with cerebral malaria is diffuse cerebral swelling, cerebral herniation, compression of the brainstem respiratory center, and respiratory arrest. In those who survive their illness without specific interventions, reversal of diffuse cerebral swelling is rapid.
Mechanical ventilation may help to preserve life while diffuse brain swelling diminishes. Intravenous hypertonic saline may work as an osmotic diuretic, directly decreasing brain swelling.
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
- Single (Outcomes Assessor)
盲法说明
Investigators assessing outcome will be blinded to the arm to which the participant was randomly assigned
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral P. falciparum parasitemia of any density
- •Blantyre Coma Score ≤2
- •No evidence of meningitis on lumbar puncture
- •Consciousness not regained after correction of hypoglycemia (if hypoglycemia is present)
- •Male or female whose age on the day of screening is between 6 months and 12 years old
- •Severely increased brain volume on magnetic resonance imaging
- •Provision of consent by guardian
- •Willingness to return for 1, 6, and 12 month post-randomization follow-up visits
排除标准
- •Gross malnutrition as evidenced by peripheral edema, hair color changes, or severe wasting
- •Advanced Human Immunodeficiency Virus (HIV) disease - defined as known HIV positive status and evidence of severe wasting
- •Evidence of recent head trauma by history or physical examination
- •Pneumonia as evidenced by oxygen saturation on room air of <85%
- •Gastroenteritis and shock as evidenced by capillary refill >3 seconds or skin tenting
研究组 & 干预措施
Mechanical ventilation
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intubation and mechanical ventilation for a maximum of 7 days
干预措施: Mechanical ventilation (Other)
Hypertonic saline
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intravenous 3% hypertonic saline for a maximum of 7 days
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
Number of Participants Who Died
时间窗: Within 7 days of randomization
Alive or dead
次要结局
- Neurodevelopmental Disability(1 year)
研究者
Terrie Taylor
Professor
Michigan State University