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

Phase 1

• Conditions: Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl; MedDRA version: 21.1Level: LLTClassification code 10070512Term: Hypoxic-ischemic encephalopathySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000836-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Any newborn eligible for hypothermic treatment according to Italian Recommendation for the treatment of perinatal asphyxia (SIN raccomandation 2012):
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Neonates will not be recruited into the study if at least one of the following criteria is found:
- 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
Main Objective: To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at the end of the starting bolus, after 24-48-72 hours infusion and after 96 hours from starting bolus will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.;Secondary Objective: To evaluate the safety of the Fentanyl regimen (load of 1-2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 0,5-1 mcg/kg/h for TH and heating fase) by recording drug side effect;Primary end point(s): Drug plasma concentrations at the end of the starting bolus, after 24-48-72 hours infusion and after 96 hours from starting bolus will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be<br>determined.;Timepoint(s) of evaluation of this end point: after 24-48-72 hours infusion and after 96 hours from starting bolus