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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897452
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Elisabeth Norman, Lund University

Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2014
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897452
Other Study ID Numbers  ICMJE EU-Grant 223767
2011-000310-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisabeth Norman, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Vineta Fellman, Professor Dep. of Pediatrics, Lund University, Sweden
PRS Account Lund University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP