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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159262
First Posted: July 9, 2010
Last Update Posted: August 13, 2015
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 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).

Condition Intervention Phase
Sedation Drug: Midazolam Drug: Fentanyl/Morphine Drug: Dexmedetomidine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 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:
  • Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion [ Time Frame: During study drug administration (6 to 24 hours) ]

Secondary Outcome Measures:
  • Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion [ Time Frame: During Study drug administration (6 to 24 hours) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 ]

Enrollment: 36
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine 0.05 mcg/kg
Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
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 0.1 mcg/kg
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
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 0.2 mcg/kg
Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
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

  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 44 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 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.
  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): NCT01159262


Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Miller Children's Hospital
Long Beach, California, United States, 90806
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
University of California San Francisco, Department of Pediatrics, Division of Neonatology
San Francisco, California, United States, 94143-0734
Dept. of Anesthesia, SUMC
Stanford, California, United States, 94305
United States, Florida
University of Miami - Miller School of Medicine, Department of Anesthesiology
Miami, Florida, United States, 33136
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit, University of Louisville
Louisville, Kentucky, United States, 40202
United States, North Carolina
Duke University Medical Center, Department of Anesthesiology
Durham, North Carolina, United States, 27710
United States, Ohio
Akron Children's Hospital Medical Center
Akron, Ohio, United States, 44308
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Greenville, South Carolina, United States, 29605
United States, West Virginia
West Virginia University School of Medicine
Morgantown, West Virginia, United States, 26506
Guatemala
Zona 11 Guatemala, Guatemala, C.P. 01011
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: NCT01159262     History of Changes
Other Study ID Numbers: DEX-09-08
First Submitted: June 30, 2010
First Posted: July 9, 2010
Results First Submitted: January 24, 2014
Results First Posted: December 12, 2014
Last Update Posted: August 13, 2015
Last Verified: July 2015

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
Initially intubated and mechanically ventilated neonates

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