Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study
- Conditions
- Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanylMedDRA version: 21.1Level: LLTClassification code: 10070512Term: Hypoxic-ischemic encephalopathy Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-516076-15-00
- Lead Sponsor
- Azienda Ospedaliero Universitaria Di Modena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
- Known genetic or chromosomal disorders or major malformation - No central venous line placement - No written parental consent to participate following informed consent interview
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method