High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Successful extubation from mechanical ventilation
研究概览
简要总结
The optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants.
详细描述
A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborn infant less than 32 weeks gestation with the diagnosis of apnea
排除标准
- •newborn infants with gestational age more than 32 weeks.
- •newborn infant with congenital malformations or chromosomal anomalies.
研究组 & 干预措施
High dose caffeine
High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base)
干预措施: Caffeine citrate (Drug)
Low dose caffeine
Low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine.
干预措施: Caffeine citrate (Drug)
结局指标
主要结局
Successful extubation from mechanical ventilation
时间窗: 72 hours after extubation from mechanical ventilation
Need of re-intubation within 72 hours of extubation from mechanical ventilation
次要结局
- Hydrocephalus(Expected 8 weeks)
- length of hospital stay(Expected 8 weeks)
- Duration of mechanical ventilation and oxygen support(Expected 4 to 6 weeks postnatal age)
- Necrotising enterocolitis(Expected 6 weeks)
- Caffeine side effects.(Expected 6 weeks)
- Chronic lung disease(By 36 weeks corrected gestational age)
- Retinopathy of prematurity(Expected 8 weeks)
- Apnea of prematurity(Expected average of 8 weeks post natal age)
- Intraventricular haemorrhage(Expected 2 weeks)
- Periventricular leukomalacia(Expected 8 weeks)
- Neonatal mortality(Expected 8 weeks)
研究者
Nehad Nasef
Associate Professor
Mansoura University Children Hospital