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

• ClinicalTrials.gov Identifier: NCT03897452
• Recruitment Status: Completed
• First Posted: April 1, 2019
• Last Update Posted: April 1, 2019
• Sponsor: Lund University
• Collaborator: Karolinska Institutet
• Information provided by (Responsible Party): Elisabeth Norman, Lund University

Tracking Information

• First Submitted Date: February 13, 2019
• First Posted Date: April 1, 2019
• Last Update Posted Date: April 1, 2019
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: December 31, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2019)

• Pharmacokinetics; fentanyl clearance [ Time Frame: 48 hours ]
  Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
• Pharmacokinetics; fentanyl clearance [ Time Frame: 6 hours ]
  The serum concentration values will be analysed as Area under the curve, AUC
• Pharmacodynamics; Amplitude integrated electroencephalography (aEEG) [ Time Frame: 6 hours ]
  Background activity
• Pharmacodynamics; Amplitude integrated electroencephalography (aEEG), [ Time Frame: 6 hours ]
  Seizure activity

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 29, 2019)

• Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
  Change in heart rate
• Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
  Change in mean arterial blood pressure
• Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
  Change in near infrared spectroscopy
• 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)
• Pharmacodynamics, hormonal response [ Time Frame: 48 hours ]
  Blood levels of cortisol

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain

Intervention

Drug: Fentanyl (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 Arms

Experimental: Fentanyl for procedural pain

A dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement.

This is not an RCT with several arms.

Intervention: Drug: Fentanyl (5 microgram/ml) prediluted ampoules

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2019): 32
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2014
• Actual Primary Completion Date: December 31, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 28 Days (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03897452
• Other Study ID Numbers: EU-Grant 223767; 2011-000310-19 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elisabeth Norman, Lund University
• Study Sponsor: Lund University
• Collaborators: Karolinska Institutet

Investigators

• Principal Investigator: Vineta Fellman, Professor; Dep. of Pediatrics, Lund University, Sweden

• PRS Account: Lund University
• Verification Date: March 2019