Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Episodes of Intermittent Hypoxia Per Hour
研究概览
简要总结
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
详细描述
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.
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
- None
入排标准
- 年龄范围
- 33 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
- •Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
- •Previously tolerated clinical treatment with caffeine
- •Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
- •Parental consent to enroll in pilot study
排除标准
- •Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
- •Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
- •Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
- •Anticipated inability to meet protocol requirements
研究组 & 干预措施
Caffeine
Caffeine citrate 6 mg/kg/day
干预措施: Caffeine citrate 6 mg/kg/day (Drug)
结局指标
主要结局
Episodes of Intermittent Hypoxia Per Hour
时间窗: 35, 36, 37, 38 weeks postmenstrual age
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Number of Seconds of Intermittent Hypoxia Per Hour
时间窗: 35, 36, 37, 38 weeks postmenstrual age
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
次要结局
未报告次要终点
研究者
Carl Hunt
Research Professor of Pediatrics
American SIDS Institute