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

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.
• 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.