NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study

NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03897452

Enrollment

Registered

2019-04-01

Start date

2012-11-30

Completion date

2014-12-31

Last updated

2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

analgesia, neonates, procedural pain, pain assessment, physiological response, pharmacogenetics

Brief summary

The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.

Interventions

DRUGFentanyl (5 microgram/ml) prediluted ampoules

Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure. Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Inclusion criteria

* Clinical indication for analgesia before any of following procedures; 1. insertion of peripheral IV-catheter 2. insertion of arterial cannula 3. insertion of chest tube 4. other skin breaking procedure. * Possibility to obtain blood samle after the procedure (indwelling line) * Infants all gestational ages. * Postnatal age 0-28 days * Informed written parental concent

Exclusion criteria

* Concurrent or previous opioid administration (72 h interval required) * Abdominal surgery * Major chromosomal anomaly * Neonatal encephalopathy * Use of muscle relaxant * Hypothermia treatment after hypoxic-ischemic insult * Clinical or biochemical evidence of hepatic failure * Participation in other intervention trial

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics; fentanyl clearance	48 hours	Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)	6 hours	Background activity
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),	6 hours	Seizure activity

Secondary

Measure	Time frame	Description
Pharmacodynamics, change in vital parameters	6 hours	Change in heart rate
Pharmacodynamics, behavioural response	6 hours	Pain assessment with the Premature Infant Pain Profile-revised (PIPP) score for procedural pain (0-21, with the highest value if strong pain in extremely preterm infants)
Pharmacodynamics, hormonal response	48 hours	Blood levels of cortisol

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026