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

Hospira, now a wholly owned subsidiary of Pfizer0 sites6 target enrollmentMarch 2012

ConditionsAnesthesia

InterventionsDexmedetomidine Midazolam Fentanyl Morphine

DrugsDexmedetomidine Midazolam Fentanyl Morphine

Overview

Phase: Phase 2
Intervention: Dexmedetomidine
Conditions: Anesthesia
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Enrollment: 6
Primary Endpoint: Percent of Subjects Requiring Rescue Midazolam for Sedation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational age.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

May 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.
•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.
•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.
•HR \< 120 bpm prior to the initiation of DEX.
•Exposure to any investigational drug within 30 days prior to DEX administration.
•Previous exposure to DEX as part of an investigational study.
•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.

Arms & Interventions

Dexmedetomidine

Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Intervention: Dexmedetomidine

Dexmedetomidine

Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Intervention: Midazolam

Dexmedetomidine

Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Intervention: Fentanyl

Dexmedetomidine

Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Intervention: Morphine

Outcomes

Primary Outcomes

Percent of Subjects Requiring Rescue Midazolam for Sedation

Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Secondary Outcomes

Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion(During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)
Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion(During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)
Amount of Rescue Medication for Analgesia During DEX Infusion(During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)
Time Spent With a Total N-PASS Score >3 During DEX Infusion(Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication)
Time to Successful Extubation(From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours))