Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01508455
First received: January 5, 2012
Last updated: September 8, 2015
Last verified: September 2015

January 5, 2012
September 8, 2015
March 2012
May 2012   (final data collection date for primary outcome measure)
Percent of Subjects Requiring Rescue Midazolam for Sedation [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ] [ Designated as safety issue: No ]
  • Number of subjects with Adverse Events [ Time Frame: 0-24 hours ] [ Designated as safety issue: Yes ]
  • Change from baseline in Vital Signs [ Time Frame: 0- 24 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01508455 on ClinicalTrials.gov Archive Site
  • Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ] [ Designated as safety issue: No ]
  • Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ] [ Designated as safety issue: No ]
  • Amount of Rescue Medication for Analgesia During DEX Infusion [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ] [ Designated as safety issue: No ]
  • Time Spent With a Total N-PASS Score >3 During DEX Infusion [ Time Frame: Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication ] [ Designated as safety issue: No ]
    The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.
  • Time to Successful Extubation [ Time Frame: From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
A Phase II/III, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational age.
Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • Drug: Dexmedetomidine
  • Drug: Midazolam
  • Drug: Fentanyl
  • Drug: Morphine
Experimental: Dexmedetomidine
Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Interventions:
  • Drug: Dexmedetomidine
  • Drug: Midazolam
  • Drug: Fentanyl
  • Drug: Morphine
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
6
May 2012
May 2012   (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 at least 6 hours of continuous IV sedation.
  2. Age: subjects must fit the following age range at screening:

    Preterm subjects ≥28 weeks through <36 weeks, gestational age;

    Note: Gestational age (in weeks) will be calculated as follows: the time elapsed between the first day of the last menstrual period and the day of enrollment.

  3. Weight: subject's weight at the time of enrollment must be >1000 g.
  4. 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.

    Note: If subject's status-post Cardio Pulmonary Bypass (CPB) was managed without pacing wires in situ, the subject must not be suspected to be in second degree or third degree heart block at the time of DEX administration.

  3. HR < 120 bpm prior to the initiation of DEX.
  4. Exposure to any investigational drug within 30 days prior to DEX administration.
  5. Previous exposure to DEX as part of an investigational study.
  6. In subjects that are ex-utero for less than 72 hours, a maternal history of poly-substance drug abuse, based upon the Investigator's clinical 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, MDZ, DEX, or other α-2 agonists.
  9. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain control.
  10. Screening ALT levels >115 U/L.
Both
28 Weeks to 36 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508455
DEX-11-06
Yes
Not Provided
Not Provided
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
September 2015

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