NCT01713127终止1 期
Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- premature infant pain profile (PIPP)
研究概览
简要总结
The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants (<37weeks of gestational age)
- •requiring ventilator care
- •informed consent
排除标准
- •major anomaly
- •48hrs after birth
- •requiring operation during drug infusion
- •cord blood pH < 7.0
- •intraventricular hemorrhage grade III or more
- •investigators decision
研究组 & 干预措施
Placebo
Placebo Comparator
5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth
干预措施: Placebo (Drug)
remifentanil
Active Comparator
0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
干预措施: remifentanil infusion (Drug)
结局指标
主要结局
premature infant pain profile (PIPP)
时间窗: 24hours after remifentanil/placebo infusion
PIPP measure during tracheal suction window period ; +/- 1hr
次要结局
- pneumothorax(up to 1 week of age)
- bronchopulmonary dysplasia(28 days of age)
- duration of ventilator care(up to 4 months of age)
- hospital day(upto 4 months of age)
- development of adverse effects(from the start of remifentanil infusion to 1 hour after end of infusion)
- intraventricular hemorrhage(up to 1 week of age)
- time to full feeding(up to 2 months of age)
- mortality(up to 4 months of age)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and InfantsMechanical VentilationNCT00419601University of Cologne24
Unknown
4 期
Remifentanil for General Anesthesia in PreeclampticsHypertension, Pregnancy-InducedPregnancy ComplicationsPre-EclampsiaNCT00567957Istanbul University50
已完成
1 期
Evaluation of Safety and Efficacy of Remifentanil in Pediatric PopulationInfant, PretermNCT01477892Seoul National University Hospital14
已完成
不适用
The Effects of Remifentanil and Remifentanil-Alfentanil Administration in ChildrenAdverse Effect of Other General AnestheticsNCT02486926Hallym University Medical Center102
招募中
1 期
Remifentanil for endotracheal intubation in neonates: a dose-finding trial.CTIS2022-501858-11-00niversitair Ziekenhuis Gent50