We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01508455
First Posted: January 12, 2012
Last Update Posted: August 23, 2017
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.
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer
  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: Dexmedetomidine Drug: Midazolam Drug: Fentanyl Drug: Morphine Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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, now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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). ]

Secondary Outcome Measures:
  • 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). ]
  • 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). ]
  • 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). ]
  • 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 ]
    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) ]

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
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)
Drug: Dexmedetomidine Drug: Midazolam Drug: Fentanyl Drug: Morphine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   28 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
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;

    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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, now a wholly owned subsidiary of Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01508455     History of Changes
Other Study ID Numbers: DEX-11-06
First Submitted: January 5, 2012
First Posted: January 12, 2012
Results First Submitted: August 2, 2013
Results First Posted: December 11, 2013
Last Update Posted: August 23, 2017
Last Verified: September 2015

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