Early versus Routine Caffeine Administration in Very Preterm Neonates- a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of bronchopulmonary dysplasia
研究概览
简要总结
With improved survival rates of preterm neonates, there is increase in number of infants with bronchopulmonary dysplasia (BPD). BPD is an important morbidity in very preterm neonates, with global pooled prevalence of 21 percent. Caffeine is a methylxanthine group of drugs. The role of Caffeine for preventing anemia of prematurity, and benefits related to long term neurodevelopmental outcomes are well-known. However, optimal timing of Caffeine initiation remains under investigation. By this study, we aim to fill this gap, and establish the benefits of early administration of Caffeine on respiratory outcomes in very preterm neonates.
This study aims to compare early versus routine Caffeine administration in very preterm neonates (born at less than 32 weeks gestational age), and its effects on incidence of BPD.
A prospective, randomized trial will be conducted at the department of Neonatology, AIIMS Nagpur, where eligible neonates will be randomized into intervention and control groups using block randomization. The intervention group will receive standard loading dose of Caffeine (20mg per kg) in the delivery room, within one hour of birth. The control group will receive the same loading dose after NICU admission (within 1 to 3 hours after birth). Respiratory parameters will be monitored.
Babies will be monitored until 36 completed weeks of corrected gestational age or till hospital discharge, whichever is later.
The primary objective is to compare the incidence of BPD in very and extremely preterm neonates receiving early versus routine Caffeine administration. Secondary objectives include short term respiratory outcomes, oxygen requirement, requirement of postnatal steroid administration, duration of NICU stay, and echocardiographic parameters of systemic blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 84.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm neonates born at less than 32 weeks gestational age admitted to NICU at AIIMS Nagpur within 3 hours after birth.
排除标准
- •Parents and guardians unwilling to provide consent for the study
- •Major Congenital malformations
- •Severe perinatal asphyxia (Apgar score less than 3 at 10 minutes, requiring positive pressure ventilation for more than 10 minutes, requiring chest compressions).
结局指标
主要结局
Incidence of bronchopulmonary dysplasia
时间窗: Requirement of supplemental oxygen at 36 completed weeks of gestational age
次要结局
- Postnatal steroid administration(till discharge)
- Echocardiographic parameters of systemic blood flow(During initial 48 hours of life)
- Requirement of invasive ventilation(Requirement of invasive ventilation for more Tham initial 12 hours)
- Total number of days on mechanical ventilation(till discharge)
- Total number of days on oxygen support(till discharge)
- Total duration of NICU stay(till discharge)
研究者
Dr Nishant Banait
All India Institute of Medical Sciences, Nagpur