A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 15
- 主要终点
- Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
研究概览
简要总结
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
- •The ability to complete all PK sampling blood draws.
- •Age: subjects must fit into 1 of the following age ranges at screening:
- •Preterm neonates ≥28 weeks through <36 weeks, gestational age; this would constitute treatment Group I.
- •Term neonates born at ≥36 weeks through ≤44 weeks gestational age; this would constitute treatment Group II.
- •Weight: subject's weight at the time of enrollment must be >1000 g.
- •Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
排除标准
- •Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:
- •Diminished consciousness from increased intracranial pressure.
- •The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
- •Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
- •Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
- •Heart rate <120 bpm prior to the initiation of study drug.
- •Exposure to any investigational drug within 30 days prior to study drug administration.
- •Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
- •Maternal history of poly-substance drug abuse, based upon the presence of 1) an abnormal urine drug screen for cocaine, opiates and/or benzodiazepines; or 2) Investigator's judgment.
- •At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
- •Subjects who have a known allergy or contraindication to fentanyl, morphine, Midazolam, DEX, or other α-2 agonists.
- •Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
- •Screening alanine aminotransferase (ALT) levels >115 U/L.
研究组 & 干预措施
Dexmedetomidine 0.05 mcg/kg
Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
干预措施: Midazolam (Drug)
Dexmedetomidine 0.05 mcg/kg
Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
干预措施: Fentanyl/Morphine (Drug)
Dexmedetomidine 0.05 mcg/kg
Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.1 mcg/kg
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
干预措施: Midazolam (Drug)
Dexmedetomidine 0.1 mcg/kg
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
干预措施: Fentanyl/Morphine (Drug)
Dexmedetomidine 0.1 mcg/kg
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.2 mcg/kg
Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
干预措施: Midazolam (Drug)
Dexmedetomidine 0.2 mcg/kg
Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
干预措施: Fentanyl/Morphine (Drug)
Dexmedetomidine 0.2 mcg/kg
Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
时间窗: During study drug administration (6 to 24 hours)
次要结局
- Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)(During study drug administration (6 to 24 hours))
- Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)(During study drug administration (6 to 24 hours))
- Time to Successful Extubation in DEX-exposed Subjects(From start of DEX administration to extubation of each subject up to 7 days post-infusion)
- Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)(During study drug administration (6 to 24 hours))
- Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion(During Study drug administration (6 to 24 hours))
- Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)(During study drug administration (6 to 24 hours))
- Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)(During Study drug administration (6 to 24 hours))
- Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)(During study drug administration (6 to 24 hours))