Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

NCT01159262 | Completed Phase 2 Results DMC

• 1 other identifier: DEX-09-08
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 18

Brief Summary

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

Conditions

Sedation

Keywords

Initially intubated and mechanically ventilated neonates

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion

  During study drug administration (6 to 24 hours)

Secondary Outcomes (8)

• Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion

  During Study drug administration (6 to 24 hours)

• Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)

  During Study drug administration (6 to 24 hours)

• Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)

  During study drug administration (6 to 24 hours)

• Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)

  During study drug administration (6 to 24 hours)

• Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)

  During study drug administration (6 to 24 hours)

Study Arms (3)

Dexmedetomidine 0.05 mcg/kg

EXPERIMENTAL

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

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

Dexmedetomidine 0.1 mcg/kg

EXPERIMENTAL

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

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

Dexmedetomidine 0.2 mcg/kg

EXPERIMENTAL

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

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

Interventions

Midazolam DRUG

Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion

Dexmedetomidine 0.05 mcg/kg; Dexmedetomidine 0.1 mcg/kg; Dexmedetomidine 0.2 mcg/kg

Fentanyl/Morphine DRUG

Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine 0.05 mcg/kg; Dexmedetomidine 0.1 mcg/kg; Dexmedetomidine 0.2 mcg/kg

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine 0.05 mcg/kg; Dexmedetomidine 0.1 mcg/kg; Dexmedetomidine 0.2 mcg/kg

Eligibility Criteria

• Age: 28 Weeks - 44 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 a minimum of 6 hours of continuous IV sedation.
• The ability to complete all PK sampling blood draws.
• 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.
• 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.
• Heart rate \<120 bpm prior to the initiation of study drug.
• Exposure to any investigational drug within 30 days prior to study drug administration.
• Previous exposure to Dexmedetomidine (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.
• 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, Midazolam, DEX, or other α-2 agonists.
• Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
• Screening alanine aminotransferase (ALT) levels \>115 U/L.

Sponsors & Collaborators

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

Study Sites (18)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California San Francisco, Department of Pediatrics, Division of Neonatology

San Francisco, California, 94143-0734, United States

Location

Dept. of Anesthesia, SUMC

Stanford, California, 94305, United States

Location

University of Miami - Miller School of Medicine, Department of Anesthesiology

Miami, Florida, 33136, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

Kosair Charities Pediatric Clinical Research Unit, University of Louisville

Louisville, Kentucky, 40202, United States

Location

Duke University Medical Center, Department of Anesthesiology

Durham, North Carolina, 27710, United States

Location

Akron Children's Hospital Medical Center

Akron, Ohio, 44308, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

West Virginia University School of Medicine

Morgantown, West Virginia, 26506, United States

Location

Unknown Facility

Zona 11 Guatemala, C.P. 01011, Guatemala

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

Midazolam; Fentanyl; Morphine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marcelo Garcia de Rocha MD, Global Medical Director
• 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 13, 2015
• Results First Posted: December 12, 2014

Record last verified: 2015-07

Locations

US (17); GU (1)