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临床试验/CTIS2024-516076-15-00
CTIS2024-516076-15-00进行中(未招募)1 期

Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study - FentanylTH

Azienda Ospedaliero Universitaria Di Modena0 个研究点目标入组 20 人开始时间: 2024年7月2日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 17(—)
性别
All

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

研究者

发起方
Azienda Ospedaliero Universitaria Di Modena

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