Overview
Sponsor-declared trial summary
Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration.
Key facts
- Sponsor
- Azienda Ospedaliero Universitaria Di Modena
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516076-15-00
- EudraCT number
- 2020-000836-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic
To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration.
Secondary objectives 1
- To evaluate the safety of the Fentanyl regimen
Conditions and MedDRA coding
Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10070512 | Hypoxic-ischemic encephalopathy | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - 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 1
- - Known genetic or chromosomal disorders or major malformation - No central venous line placement - No written parental consent to participate following informed consent interview
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1075324 · ATC
- Active substance
- Fentanyl Citrate
- Substance synonyms
- FENTANYL DIHYDROGEN CITRATE, 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLIC ACID, N-(1-PHENETHYL-4-PIPERIDYL)-N-PHENYL-PROPANAMIDE
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero Universitaria Di Modena
- Sponsor organisation
- Azienda Ospedaliero Universitaria Di Modena
- Address
- Largo Del Pozzo 71
- City
- Modena
- Postcode
- 41124
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero Universitaria Di Modena
- Contact name
- Licia Lugli
Public contact point
- Organisation
- Azienda Ospedaliero Universitaria Di Modena
- Contact name
- Licia Lugli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-02 | Italy | Acceptable 2024-07-29
|
2024-08-05 |