Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Duration of Respiratory Support
研究概览
简要总结
Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine
详细描述
It will be a randomized control trial, patients will be randomly assigned to receive caffeine in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life .
Preparation and administration of caffeine will be performed by a Neonatal intensive care unit (NICU) nurse.
Statistical Evaluation:
Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test will be used. For group comparisons, the Student T test will be used in normal distribution and the Mann-Whitney U test will be used in case of abnormal distribution.
For repeating measurements, variance analyses and Friedman variance analyses will be used. For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation will be used in accordance with the type and distribution of the variable. A P value <.05 was considered statistically significant. Informed consent will be obtained from parents, and the study will be approved by the local ethical committee.
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 (Investigator)
入排标准
- 年龄范围
- 1 Hour 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea .
排除标准
- •Newborn infants with gestational age > 32 weeks.
- •Newborn infants with congenital malformations and chromosomal anomalies.
- •Newborn infants with apnea of other causes .
研究组 & 干预措施
Prophylactic caffeine citrate
Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .
干预措施: Prophylactic caffeine citrate (Drug)
Therapeutic caffeine citrate
Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
干预措施: Therapeutic caffeine citrate (Drug)
结局指标
主要结局
Duration of Respiratory Support
时间窗: 60 days from NICU admission
次要结局
- Days of apnea free(60 days from NICU admission)
- length of hospital stay(60 days from NICU admission)
- Head ultrasound results(14 days from NICU admission)
- Necrotizing Enterocolitis(30 days from NICU admission)
- Retinopathy of prematurity(60 days from NICU admission)
研究者
Nehad Nasef
Principle Invistigator
Mansoura University Children Hospital