Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at zero-time, within 30 min of the administration of the starting bolus, after 24-48-72-96 hours infusion will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.
研究概览
简要总结
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •newborn eligible for hypothermic treatment the treatment of perinatal asphyxia - a gestational age ≥ 35 weeks and a birth weight > 1.8 kg; - with Apgar Score at 5 min ≤ 5 or with continued resuscitation at 10 min postnatal or with 1 h postnatal blood gas analysis pH<7.0 or base deficit>12 - clinical signs of encephalopathy - moderate to severe aEEG anomalies or seizures - neuroprotective treatment by controlled hypothermia <6 h postnatal life - parental written informed consent for participation in the study obtained - study analgesic treatment available
排除标准
- •Known genetic or chromosomal disorders or major malformation - No central venous line placement - No written parental consent to participate following informed consent interview
结局指标
主要结局
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at zero-time, within 30 min of the administration of the starting bolus, after 24-48-72-96 hours infusion will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at zero-time, within 30 min of the administration of the starting bolus, after 24-48-72-96 hours infusion will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.
次要结局
- To evaluate the safety of the Fentanyl regimen (load of 2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 1 mcg/kg/h for TH and heating fase) by recording drug side effect
研究者
Licia Lugli
Scientific
Azienda Ospedaliero Universitaria Di Modena