Safety Assessment for Early Caffeine Weaning: SAFE-CAFE PILOT Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Proportion of Infants with recurrence of Clinically Significant Apnea from Randomization till discharge in each of the two groups
研究概览
简要总结
Apnea of prematurity (AOP) is a common developmental disorder affecting preterm infants due to their immature respiratory control.It is characterised by episodes of breathing cessation lasting 20 seconds or longer often accompanied by bradycardia, cyanosis or pallor. The prevalence of AOP decreases as gestational age increases with higher incidence in infants born <28 weeks gestation.
Caffeine has emerged as preferred pharmacological treatment for AOP and is widely used in neonatal intensive care units. It has shown to reduce the duration of mechanical ventilation, lower risk of bronchopulmonary dysplasia, and improve neurodevelopment outcomes. Despite its efficacy, there is lack of consensus regarding optimal duration of caffeine therapy.
Clinical practises vary regarding when to discontinue caffeine therapy. Some units advocate for extended use until infants reach 34-35 weeks post menstrual age (PMA) or beyond, while others opt for early discontinuation after seven consecutive apnea-free days. The decision to stop caffeine is often based on decreasing risk of AOP as PMA increases.
Extending caffeine therapy may reduce the risk of apnea recurrence however, prolonged use comes with challenges such as tachycardia, feed intolerance, and reduced weight gain. Additionally, keeping infants on caffeine until a certain PMA threshold may prolong hospital stays and increase care costs.
Conversely, a shorter course of caffeine therapy may heighten the risk of apnea recurrence, necessitating a balance between the benefits and potential drawbacks of continued caffeine use. Existing literature on duration of caffeine therapy and its impact on AOP recurrences limited, with few controlled trials addressing this issue.
Our study aims to address this gap by comparing the recurrence of AOP between two groups : Group 1, where caffeine is discontinued at 32 weeks PMA, and group 2 where caffeine is continued till fixed period of 34 week sand stopped. This research will contribute to a better understanding of optimal caffeine management in preterm infants and guide clinical decision making regarding AOP treatment duration.
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 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates with a gestational age ranging from 26 to 31+6 weeks admitted in NICU and started on caffeine citrate (
- •For treatment of apnea of prematurity, 2.All neonates admitted with respiratory distress requiring CPAP support).
排除标准
- •1.Major congenital anomalies 2.Grade III and grade IV Intraventricular hemorrhage 3.Drugs that can cause CNS depression.
- •Antiepileptics, Morphine, Midazolam 4.Babies born with Birth Asphyxia 5.Baby on respiratory support higher than HFNC of 3L flow and 25% FiO2 6.Receiving treatment for Sepsis / PDA at the time of randomisation.
结局指标
主要结局
Proportion of Infants with recurrence of Clinically Significant Apnea from Randomization till discharge in each of the two groups
时间窗: Discharge of baby from hospital
次要结局
- Occurrence of extrauterine growth restriction in the two groups.(Discharge of baby from hospital)
- Risk of retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and abnormal cranial ultrasound findings.(Till 3 months corrected ago follow up)
- Gestation-specific day of recurrence of apnea post-caffeine discontinuation.(Discharge of baby from hospital)
- Recurrence risk in subgroups based on gestational age at birth and severity of respiratory illness.(discharge of baby from hospital)
- To assess the relationship between apnea recurrence after caffeine cessation and the number of days off CPAP before recurrence.(Discharge of baby from hospital)
- Compare incidence of BPD in the two groups(Discharge from hospital)
- Cost-effectiveness analysis for early discontinuation.(Discharge from hospital)
- Neurodevelopmental outcome at 3 months post-caffeine discontinuation.(Till 3 months corrected age follow up)
研究者
Dr Abhishek S Gowdar
AIIMS RAIPUR