Dexmedetomidine Use During Therapeutic Hypothermia Treatment for Neonates With Hypoxic-ischemic Encephalopathy: The Cool DEX Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) parameter of area under the curve (AUC)
研究概览
简要总结
The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.
详细描述
The goal of this proposal is to determine the pharmacokinetics (PK) of dexmedetomidine (DEX) in newborns in the neonatal intensive care unit (NICU) receiving therapeutic hypothermia (TH) for moderate to severe hypoxic-ischemic encephalopathy (HIE). In newborns with HIE, TH for 72 hours is the standard therapy to mitigate brain damage. Most HIE patients receive mechanical ventilation during TH and are thus sedated with morphine. Unfortunately, morphine has negative side effects and does not specifically prevent shivering. Prevention of shivering is critical to success of TH, as shivering negates cooling. DEX is a particularly promising alternative sedative because it does prevent shivering and is already used in NICUs for sedation and pain management. In newborns, DEX PK data in the setting of TH is not available and needs to be determined to properly dose DEX for HIE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns 36 weeks gestation or older with moderate to severe hypoxic-ischemic encephalopathy identified and treated with therapeutic hypothermia in the Seattle Children's Hospital neonatal intensive care unit.
- •Cooled infants who are initially intubated and mechanically ventilated.
- •Infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering.
- •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
- •Known chromosomal anomalies.
- •Newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line.
- •Patients with known cyanotic congenital heart defects
- •Patients who are participating in another clinical trial.
- •Patients who received DEX prior to enrollment in the study
- •At the discretion of the Investigator, subjects in whom the risk of Dexmedetomidine treatment is expected to exceed its benefits.
研究组 & 干预措施
Dexmedetomidine group
Neonates with hypoxic-ischemic encephalopathy will receive a dexmedetomidine maintenance infusion of 0.4 mcg/kg/hr during treatment with therapeutic hypothermia and during re-warming (78 hours total).
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pharmacokinetic (PK) parameter of area under the curve (AUC)
时间窗: Day 1 to Day 4
Estimate PK parameter of AUC in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.
Pharmacokinetic (PK) parameter of terminal half-life
时间窗: Day 1 to Day 4
Estimate PK parameter of terminal half-life in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.
Pharmacokinetic (PK) of volume of distribution
时间窗: Day 1 to Day 4
Estimate PK parameter of volume of distribution in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.
Pharmacokinetic (PK) parameter of clearance
时间窗: Day 1 to Day 4
Estimate PK parameter of clearance in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.
次要结局
- Efficacy of dexmedetomidine at preventing shivering(Day 1 to Day 3)
- Safety of dexmedetomidine in neonatal subjects. (composite outcome will include: adverse events, physical examination findings, and vital signs)(Day 1 to Day 4)
研究者
Ryan McAdams
Associate Professor of Pediatrics, Neonatologist
Seattle Children's Hospital