Clinical trial • Phase I | Phase III • Neurology

FENTANYL CITRATE for Hypoxic-ischemic encephalopathy | Perinatal asphyxia

Phase I | Phase III trial of FENTANYL CITRATE for Hypoxic-ischemic encephalopathy | Perinatal asphyxia. 20 participants.

Overview

Phase I | Phase III trial across 1 site in Italy.

Recruits 20 paediatric patients.

Vulnerable Population: Neonates/newborns (infants); parental written informed consent required for participation; assent not applicable.

{"criterion_text":"- 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"}

{"criterion_text":"- Known genetic or chromosomal disorders or major malformation - No central venous line placement - No written parental consent to participate following informed consent interview"}

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Drug plasma concentrations measured at time 0, within 30 minutes of the starting bolus, and after 24, 48, 72, and 96 hours of infusion; determination of maximum-minimum concentration (Cmax-min) and clearance."}

{"endpoint_text":"- 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","definition_or_measurement_approach":"Safety assessed by recording drug side effects; dosing regimen specified as a 2 mcg/kg loading dose followed by continuous infusion at 1 mcg/kg/h."}

Planned Sample Size: 20
Recruitment Window Months: 42
Consent Approach: Parental written informed consent required from parents for participation; assent not applicable; languages available not specified.

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