A Phase II/Ill, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine inPreterm Subjects Ages 28 Weeks to < 36 Weeks Gestational Age

Phase 1

• Conditions: Initially intubated and mechanically ventilated pretermsubjects ... 28 weeks through < 36 weeks, gestational age, having a weight of > 1000 g, in an intensivecare setting anticipated to require at least 6 hours of continuous intravenous sedation.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-000408-71-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: A
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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 had to be in the following age range at screening:
Preterm subjects z 28 weeks through < 36 weeks, gestational age;
Note: Gestational age (in weeks) was calculated as follows: the time elapsed between the first
day of the last menstrual period and the day of enrollment. 14
3. Weight: subject's weight at the time of enrollment had to be > 1000 g.
4. Subject's parent(s) or legal guardian(s) had voluntarily signed and dated the informed consent
document approved by the IRB/ IEC.
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
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 prohibited an evaluation of sedation such as:o Diminished consciousness from increased intracranial pressure.
O 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.
O 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 were in situ.
Note: If subject's status-post Cardiopulmonary Bypass (CPB) was being managed without
pacing wires in situ, the subject could not have been 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 were 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 was expected to
exceed its benefits.
8. Subjects who had 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 Alanine Aminotransferase (ALT) levels > 115 UIL.

Study & Design

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