Higher versus Standard Caffeine dosing in Prevention of Apnoea of Prematurity: A Randomized Controlled Trial (HI-CAF trial)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- The proportion of apnoea of prematurity
研究概览
简要总结
Our study, titled "Higher versus Standard Caffeine dosing in Prevention of Apnoea of Prematurity (HI-CAF trial)," investigates the efficacy of a higher dose of caffeine in reducing Apnea of Prematurity (AoP) compared to standard dosing. With a global rise in premature births, the research addresses the need for optimal management, particularly in low- and middle-income countries. The study design is a randomized controlled trial conducted in an Indian neonatal unit, focusing on neonates below 32 weeks gestation. The primary outcome is the proportion of Apnoea of Prematurity, with secondary outcomes including the rates of failure of extubation, Incidence of PDA, NEC, IVH, PVL, ROP and AKI, Duration of respiratory support,
The time to reach full enteral feeding, Number of NPO hours, The incidence of Hypertension,
Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay), The incidence of Seizures, Severe adverse events, BPD and Mortality. The methodology involves randomization into higher and standard dose caffeine groups, and the study aims to contribute valuable insights to the inconsistent data on caffeine dosing. The study period is for 18 months, and the statistical analysis will employ chi-square tests and t-tests, presenting results with a significance threshold of p < 0.05. The study seeks to address gaps in literature, particularly in the context of limited evidence from low- and middle-income countries, and aims to provide practical implications for neonatal care.
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
- 0.00 Day(s) 至 28.00 Day(s)(—)
- 性别
- All
入选标准
- •All neonates less than 30 weeks of gestation and Neonates between 30+1 to 31+6 who develop recurrent apnoea.
排除标准
- •Major Congenital anomaly or Chromosomal abnormalities and Parents who do not consent.
结局指标
主要结局
The proportion of apnoea of prematurity
时间窗: Upto 28 days of life
次要结局
- The incidence of Seizures.
- Severe adverse events.
- BPD
- Mortality
- The rates of failure of extubation.(anytime during hospital stay.)
- Incidence of PDA, NEC, IVH, PVL, ROP and AKI.
- Duration of respiratory support.(anytime during hospital stay.)
- The time to reach full enteral feeding.(anytime during hospital stay.)
- Number of NPO hours(anytime during hospital stay.)
- The incidence of Hypertension.
- Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay)
研究者
Dr Asha M N
IMS and SUM Hospital
