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

Phase 1

Not yet recruiting

• Conditions: Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl

• Registration Number: 2024-516076-15-00
• Lead Sponsor: Azienda Ospedaliero Universitaria Di Modena

Brief Summary

To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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
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.		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.

Secondary Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliero Universitaria Di Modena

🇮🇹Modena, Italy

Licia Lugli

Site contact

+390594225868

lugli.licia@aou.mo.it