A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study ofDexmedetomidine in Neonates Ages = 28 Weeks to = 44 Weeks Gestational Age - DEX-09-08

Hospira Inc0 个研究点目标入组 42 人开始时间: 2017年2月27日最近更新: 2017年3月13日

试验速览

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•1. Initially intubated and mechanically ventilated pediatric subjects in an intensive
•care setting anticipated to require a minimum of 6 hours of continuous IV
•2. The ability to complete all PK sampling blood draws.
•NB: The presence of an indwelling venous or arterial catheter for blood sampling;
•with an umbilical venous or arterial catheter is preferred but not required.
•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.
•Gestational age (in weeks) will be calculated as follows: the time elapsed between
•the first day of the last menstrual period and the day of delivery
•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).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 42
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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. HR < 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 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.
•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,
•MDZ, DEX, or other a-2 agonists.
•9. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for
•sedation and pain control.
•10. Screening ALT levels > 115 U/L.

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