NCT03298347Unknown不适用
Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the rate of AOP
研究概览
简要总结
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.
详细描述
Less evidences about more dose of caffein used in preterm infants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age less than 32 weeks;
- •appear AOP;
- •parents'consents are obtained.
排除标准
- •major congenital abnormalities;
- •Parents' rejection
研究组 & 干预措施
80mg/kg of caffeine
Experimental
80mg/kg of caffeine is given to treat AOP.
干预措施: 80mg/kg of caffeine (Drug)
20mg/kg of caffeine
Active Comparator
20mg/kg of caffeine is given to treat AOP.
干预措施: 20mg/kg of caffeine (Drug)
结局指标
主要结局
the rate of AOP
时间窗: within 100 days
AOP appears again in preterm infants
次要结局
未报告次要终点
研究者
Ma Juan
Director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (1)
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