Status:
COMPLETED
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
Lead Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Sedation
Eligibility:
All Genders
28-44 years
Phase:
PHASE2
PHASE3
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01159262
Start Date
July 1 2010
End Date
August 1 2011
Last Update
August 13 2015
Active Locations (18)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Miller Children's Hospital
Long Beach, California, United States, 90806
3
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
4
University of California San Francisco, Department of Pediatrics, Division of Neonatology
San Francisco, California, United States, 94143-0734