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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508455
• Other study ID #: DEX-11-06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 5, 2012
• Last updated: March 16, 2017
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Hospira, now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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 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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine

• Midazolam

• Fentanyl

• Morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects Requiring Rescue Midazolam for Sedation		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	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).
Secondary	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).
Secondary	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).
Secondary	Time Spent With a Total N-PASS Score >3 During DEX Infusion	The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.	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
Secondary	Time to Successful Extubation		From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)