Safety and Efficacy Study of Dexmedetomidine in Pediatrics Ages >= 28 Weeks to <= 44 Weeks Gestational Age - Full Text View

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 unit care unit (NICU), cardiac intensive unit care unit (CICU), or pediatric intensive unit care unit (PICU).

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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:

Drug Information available for: Fentanyl Fentanyl citrate Midazolam hydrochloride Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:

Use of rescue medication for sedation and analgesia [ Time Frame: 6 to 34 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of rescue medication for analgesia during study drug infusion [ Time Frame: 6 to 24 hours ] [ Designated as safety issue: Yes ]
Amount of rescue medication for sedation during study drug infusion. [ Time Frame: 6 to 24 hours ] [ Designated as safety issue: Yes ]
Change from baseline in vital signs, respiratory rate and oxygenation measures during study drug infusion [ Time Frame: 6 to 24 hours ] [ Designated as safety issue: Yes ]
Time spent with an N-PASS score >3 during study drug administration [ Time Frame: 6 to 24 hours ] [ Designated as safety issue: Yes ]
Time from study drug administration to extubation. [ Time Frame: 6 to 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	42
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 scores and investigator discretion Drug: Fentanyl Per package insert, N-PASSS 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 scores and investigator discretion Drug: Fentanyl Per package insert, N-PASSS 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 scores and investigator discretion Drug: Fentanyl Per package insert, N-PASSS scores and investigator discretion. Drug: Dexmedetomidine Other Name: Precedex

Eligibility

Ages Eligible for Study:	28 Weeks to 44 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
The ability to complete all PK sampling blood draws.
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.
Weight: subject's weight at the time of enrollment must be > 1000 g.
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:

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.
Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
HR < 120 bpm prior to the initiation of study drug.
Exposure to any investigational drug within 30 days prior to study drug administration.
Previous exposure to DEX as part of an investigational study.
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.
At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
Subjects who have a known allergy or contraindication to fentanyl, morphine, MDZ, DEX, or other α-2 agonists.
Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain control.
Screening ALT levels > 115 U/L.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Medical college of Georgin Health System
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
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Akron Children's Hospital
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
Charleston, South Carolina, United States, 29425
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
United States, West Virginia
West Virginia University School of Medicine
Morgantown, West Virginia, United States, 26506
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3H 1P3
Guatemala
Unidad de Neonatologia Servicio de Alto Riesgo Hospital Roosevelt
Guatemala, Guatemala, C.P. 01011

Sponsors and Collaborators

Hospira, Inc.

More Information

No publications provided

Responsible Party:	Hospira, Inc.
ClinicalTrials.gov Identifier:	NCT01159262 History of Changes
Other Study ID Numbers:	DEX-09-08
Study First Received:	June 30, 2010
Last Updated:	September 14, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Guatemala: Ministry of Public Health and Social Assistance

Keywords provided by Hospira, Inc.:

Initially intubated and mechanically ventilated neonates

Additional relevant MeSH terms:

Midazolam
Fentanyl
Dexmedetomidine
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
Adrenergic Agents

ClinicalTrials.gov processed this record on May 16, 2013