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NCT Number: NCT03897452

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

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Procedural Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neonatal Intensive Care Unit, Skåne University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical indication for analgesia before any of following procedures;
  • insertion of peripheral IV-catheter
  • insertion of arterial cannula
  • insertion of chest tube
  • 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

Treatment and study plan

Fentanyl (5 microgram/ml) prediluted ampoules

Drug

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).

Primary outcomes

  1. Pharmacokinetics; fentanyl clearance

    Time frame: 48 hours

    Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.

  2. Pharmacokinetics; fentanyl clearance

    Time frame: 6 hours

    The serum concentration values will be analysed as Area under the curve, AUC

  3. Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)

    Time frame: 6 hours

    Background activity

  4. Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),

    Time frame: 6 hours

    Seizure activity

Secondary outcomes

  1. Pharmacodynamics, change in vital parameters

    Time frame: 6 hours

    Change in heart rate

  2. Pharmacodynamics, change in vital parameters

    Time frame: 6 hours

    Change in mean arterial blood pressure

  3. Pharmacodynamics, change in vital parameters

    Time frame: 6 hours

    Change in near infrared spectroscopy

  4. Pharmacodynamics, behavioural response

    Time frame: 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)

  5. Pharmacodynamics, hormonal response

    Time frame: 48 hours

    Blood levels of cortisol

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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