Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
NCT ID: NCT01159262
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
36 participants
INTERVENTIONAL
2010-07-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dexmedetomidine 0.05 mcg/kg
Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl/Morphine
Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine
Dexmedetomidine 0.1 mcg/kg
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl/Morphine
Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine
Dexmedetomidine 0.2 mcg/kg
Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl/Morphine
Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine
Interventions
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Midazolam
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl/Morphine
Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
28 Weeks
44 Weeks
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Miller Children's Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
University of California San Francisco, Department of Pediatrics, Division of Neonatology
San Francisco, California, United States
Dept. of Anesthesia, SUMC
Stanford, California, United States
University of Miami - Miller School of Medicine, Department of Anesthesiology
Miami, Florida, United States
Georgia Health Sciences University
Augusta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Loyola University Medical Center
Maywood, Illinois, United States
Wichita, Kansas, United States
Kosair Charities Pediatric Clinical Research Unit, University of Louisville
Louisville, Kentucky, United States
Duke University Medical Center, Department of Anesthesiology
Durham, North Carolina, United States
Akron Children's Hospital Medical Center
Akron, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Greenville, South Carolina, United States
West Virginia University School of Medicine
Morgantown, West Virginia, United States
Zona 11 Guatemala, , Guatemala
Countries
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References
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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.
Other Identifiers
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DEX-09-08
Identifier Type: -
Identifier Source: org_study_id
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