Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl MedDRA version: 21.1 Level: LLT Classification code 10070512 Term: Hypoxic-ischemic encephalopathy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: fentanyl-hameln
Product Name: Fentanyl-hameln
Product Code: [-]
Pharmaceutical Form: Solution for injection
Current Sponsor code: -
Concentration unit: Other
Concentration type: equal
Conc
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
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 12 - clinical signs of encephalopathy - moderate to severe aEEG anomalies or seizures - neuroprotective treatment by controlled hypothermia =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 determined.;Timepoint(s) of evaluation of this end point: after 24-48-72 hours infusion and after 96 hours from starting bolus | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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: - Rate of mechanically ventilated newborns during TH - Rate of apnea and/or need of respiratory support starting during TH - Need of resuscitation during TH - Need of opioid antagonist administration during TH - Incidence of hypotension during TH, defined as blood pressure below 10th centile for gestational age and postnatal age - Need of cardiovascular support drugs during TH - Rate of delayed intestinal passage (abdominal distension, gastric retention, absent/delayed evacuation, minimal enteral feeding intolerance) - Rate of bladdr globus, defined as loss of spontaneous urination with enlarged bladder and need for catheterisation - Site and severity of cerebral lesions detected by cerebral MRI The analgesic effect of Fentanyl administration, by the application of validated algometric scales for chronic pain (EDIN – Echelle Douleur Inconfort Nouveau-Nè) and acute pain (PIPP- Premature Infant Pain Profile). Efficacy of analgesic therapy is evaluated by the registration of the average heart rate of newborn during hypothermia and the presence of tremors. To evaluate drug plasma concentrations in relation to the degree of disease (moderate – severe asphyxia);Timepoint(s) of evaluation of this end point: during TH | — |
Countries
Italy
Contacts
Public ContactClinical Trial Quality Team
Azienda Ospedaliero-Universitaria di Modena
Outcome results
None listed