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: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Anesthesia
Drug: Midazolam
Drug: Fentanyl
Drug: Morphine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II/III, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥ 28 Weeks to < 36 Weeks Gestational Age

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Percent of Subjects Requiring Rescue Midazolam for Sedation [ Time Frame: Subjects were followed for an average of 14.25 hours ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine Drug: Midazolam
IV per package insert
Drug: Fentanyl
IV per package insert
Drug: Morphine
IV per package insert

  Eligibility

Ages Eligible for Study:   28 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;

  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 CPB being 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508455

Locations
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Greenville, South Carolina, United States, 29605
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided by Hospira, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01508455     History of Changes
Other Study ID Numbers: DEX-11-06
Study First Received: January 5, 2012
Results First Received: August 2, 2013
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
Guatemala: Ministry of Public Health and Social Assistance

Additional relevant MeSH terms:
Midazolam
Fentanyl
Dexmedetomidine
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 17, 2014