Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Duration of respiratory support
研究概览
简要总结
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.
The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.
The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.
详细描述
late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.
Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants at gestational age 34 0/7 through 36 6/7
- •Presented with respiratory distress
- •Require respiratory support in the form of any of the following :
- •A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.
排除标准
- •1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.
- •3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.
- •5- Late preterm with history of maternal substance abuse
研究组 & 干预措施
Caffeine citrate group
Infants receive either caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
干预措施: Caffeine citrate (Drug)
Control group
Infants received equivalent volume of saline.
干预措施: Placebo (Other)
结局指标
主要结局
Duration of respiratory support
时间窗: 28 days
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
次要结局
- Episodes of apnea(28 gays)
- Failure of extubation(28 days)
- Duration of caffeine(28 days)
- Length of hospital stay(28 days)
- Time to full enteral and oral feeding(28 days)
- Adverse effects of caffeine use(28 days)
- Caffeine withhold(28 days)
- Weight gain per day(28 days)
- Mortality(28 days)
- Readmission rate(28 days)
- Days of apnea(28 days)
研究者
Fatema Sulaiman Alhazmi
NICU Director
Ministry of Health, Saudi Arabia