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

Phase 1

Active, not recruiting

• Conditions: Initially intubated and mechanically ventilated pretermneonates = 28 weeks through < 36 weeks gestational age and term neonates born at = 36 weeks through= 44 weeks gestational age in an intensive care setting anticipated to require a minimum of 6 hours ofcontinuous IV sedation. Weight at the time of enrollment had to be > 1000 g; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-000406-38-Outside-EU/EEA
• Lead Sponsor: Hospira Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified