Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

Inclusion Criteria:

1. Initially intubated and mechanically ventilated pediatric subjects in an intensive
care setting anticipated to require at least 6 hours of continuous IV sedation.

2. Age: subjects must fit the following age range at screening:

Preterm subjects ≥28 weeks through <36 weeks, gestational age;

Note: 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 enrollment.

3. Weight: subject's weight at the time of enrollment must be >1000 g.

4. 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:

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.

Note: If subject's status-post Cardio Pulmonary Bypass (CPB) was managed without
pacing wires in situ, the subject must not be suspected to be in second degree or
third degree heart block at the time of DEX administration.

3. HR < 120 bpm prior to the initiation of DEX.

4. Exposure to any investigational drug within 30 days prior to DEX administration.

5. Previous exposure to DEX as part of an investigational study.

6. In subjects that are ex-utero for less than 72 hours, a maternal history of
poly-substance drug abuse, based upon the Investigator's clinical 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 α-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.