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

NCT01508455 | Completed Phase 2 Results DMC

• 1 other identifier: DEX-11-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

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)

Drug: Dexmedetomidine; Drug: Midazolam; Drug: Fentanyl; Drug: Morphine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Midazolam DRUG

Dexmedetomidine

Fentanyl DRUG

Dexmedetomidine

Morphine DRUG

Dexmedetomidine

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
• Subjects who have a known allergy or contraindication to fentanyl, morphine, MDZ, DEX, or other α-2 agonists.
• Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain control.
• Screening ALT levels \>115 U/L.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (4)

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15224, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

Unknown Facility

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.

  PMID: 24238862 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Fentanyl; Morphine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Marcelo Garcia da Rocha
• Organization: Hospira

marcelo.rocha@hospira.com

224-212-4424

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 12, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 23, 2017
• Results First Posted: December 11, 2013

Record last verified: 2015-09

Locations

US (4)