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

Completed · Phase 2/Phase 3

Conditions studied: Sedation

In brief

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).

Key facts

Study ID

NCT01159262

Run by

Hospira, now a wholly owned subsidiary of Pfizer

People needed

36

Starts

2010-07-01

Expected to finish

2011-08-01

Last updated by the study team

2015-08-13

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.
• Heart rate <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 Dexmedetomidine (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, Midazolam, DEX, or other α-2 agonists.
• Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
• Screening alanine aminotransferase (ALT) levels >115 U/L.

Where it is running

• 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
• Study site — 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
• Study site — Greenville, South Carolina, United States
• West Virginia University School of Medicine — Morgantown, West Virginia, United States
• Study site — Zona 11 Guatemala, Guatemala

Full record on ClinicalTrials.gov

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