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Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study
EU CTIS ID: 2024-516076-15-00
What this study is testing
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - Known genetic or chromosomal disorders or major malformation - No central venous line placement - No written parental consent to participate following informed consent interview
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.