Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01159262
First received: June 30, 2010
Last updated: July 23, 2015
Last verified: July 2015

June 30, 2010
July 23, 2015
July 2010
August 2011   (final data collection date for primary outcome measure)
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
Incidence of adverse events (AEs) [ Time Frame: 6 to 34 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01159262 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion [ Time Frame: During Study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During Study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) [ Time Frame: During study drug administration (6 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Time to Successful Extubation in DEX-exposed Subjects [ Time Frame: From start of DEX administration to extubation of each subject up to 7 days post-infusion ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sedation
  • Drug: Midazolam
    Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
  • Drug: Fentanyl/Morphine
    Per package insert, N-PASS scores and investigator discretion.
  • Drug: Dexmedetomidine
    Other Name: Precedex
  • Experimental: Dexmedetomidine 0.05 mcg/kg
    Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl/Morphine
    • Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine 0.1 mcg/kg
    Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl/Morphine
    • Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine 0.2 mcg/kg
    Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl/Morphine
    • Drug: Dexmedetomidine
Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
  2. The ability to complete all PK sampling blood draws.
  3. Age: subjects must fit into 1 of the following age ranges at screening:

    • Preterm neonates ≥28 weeks through <36 weeks, gestational age; this would constitute treatment Group I.
    • Term neonates born at ≥36 weeks through ≤44 weeks gestational age; this would constitute treatment Group II.
  4. Weight: subject's weight at the time of enrollment must be >1000 g.
  5. Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria:

  1. Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:

    • Diminished consciousness from increased intracranial pressure.
    • The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
    • Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
  2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
  3. Heart rate <120 bpm prior to the initiation of study drug.
  4. Exposure to any investigational drug within 30 days prior to study drug administration.
  5. Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
  6. Maternal history of poly-substance drug abuse, based upon the presence of 1) an abnormal urine drug screen for cocaine, opiates and/or benzodiazepines; or 2) Investigator's judgment.
  7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
  8. Subjects who have a known allergy or contraindication to fentanyl, morphine, Midazolam, DEX, or other α-2 agonists.
  9. Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
  10. Screening alanine aminotransferase (ALT) levels >115 U/L.
Both
28 Weeks to 44 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States,   Guatemala
Canada
 
NCT01159262
DEX-09-08
Yes
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
July 2015

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