Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.
详细描述
There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.
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
- None
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of any gender
- •Neonates with gestational age <32 weeks
- •Admitted within 6 hours of birth
排除标准
- •Major congenital anomalies
- •Severe birth asphyxia (Apgar <3 at 10 min)
- •Pre-existing renal anomalies
研究组 & 干预措施
Supportive Care Group
Neonates will be given supportive care without caffeine
干预措施: Supportive care (Drug)
Early Caffeine Group
Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.
干预措施: Caffeine (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: 14 days
Incidence of AKI within the first 14 days of life.
次要结局
- Duration of Acute Kidney Injury(Up to 30 days)
- Length of Hospital Stay(Up to 30 days)
- Mortality(Up to 30 days)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research