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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01159262
• Date of registration: 30/06/2010
• Primary sponsor: Hospira, Inc.
• Public title: Safety and Efficacy Study of Dexmedetomidine in Pediatrics Ages >= 28 Weeks to <= 44 Weeks Gestational Age
• Scientific 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
• Date of first enrolment: July 2010
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01159262
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, Guatemala, United States

Key inclusion & exclusion 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 a-2 agonists.

- Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation
and pain control.

- Screening ALT levels > 115 U/L.



Age minimum: 28 Weeks
Age maximum: 44 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Sedation

Intervention(s)

Drug: Dexmedetomidine

Drug: Fentanyl

Drug: Midazolam

Primary Outcome(s)

Use of rescue medication for sedation and analgesia [Time Frame: 6 to 34 hours]

Secondary Outcome(s)

Amount of rescue medication for sedation during study drug infusion. [Time Frame: 6 to 24 hours]

Change from baseline in vital signs, respiratory rate and oxygenation measures during study drug infusion [Time Frame: 6 to 24 hours]

Incidence of rescue medication for analgesia during study drug infusion [Time Frame: 6 to 24 hours]

Time from study drug administration to extubation. [Time Frame: 6 to 24 hours]

Time spent with an N-PASS score >3 during study drug administration [Time Frame: 6 to 24 hours]

Secondary ID(s)

DEX-09-08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors