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

Sedation Clinical Trial

Official title:

A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159262
• Other study ID #: DEX-09-08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 30, 2010
• Last updated: July 23, 2015
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGuatemala: Ministry of Public Health and Social Assistance
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 44 Weeks

Eligibility

Inclusion Criteria:

1. Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.

2. The ability to complete all PK sampling blood draws.

3. 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.

4. Weight: subject's weight at the time of enrollment must be >1000 g.

5. 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.

3. Heart rate <120 bpm prior to the initiation of study drug.

4. Exposure to any investigational drug within 30 days prior to study drug administration.

5. Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.

6. 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.

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, Midazolam, DEX, or other a-2 agonists.

9. Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.

10. Screening alanine aminotransferase (ALT) levels >115 U/L.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Midazolam
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
• Fentanyl/Morphine
Per package insert, N-PASS scores and investigator discretion.
• Dexmedetomidine

Locations

Country	Name	City	State
United States	Akron Children's Hospital Medical Center	Akron	Ohio
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Duke University Medical Center, Department of Anesthesiology	Durham	North Carolina
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Miller Children's Hospital	Long Beach	California
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Kosair Charities Pediatric Clinical Research Unit, University of Louisville	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami - Miller School of Medicine, Department of Anesthesiology	Miami	Florida
United States	West Virginia University School of Medicine	Morgantown	West Virginia
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	University of California San Francisco, Department of Pediatrics, Division of Neonatology	San Francisco	California
United States	Dept. of Anesthesia, SUMC	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Countries where clinical trial is conducted

United States,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion		During study drug administration (6 to 24 hours)	Yes
Secondary	Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion		During Study drug administration (6 to 24 hours)	Yes
Secondary	Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)		During Study drug administration (6 to 24 hours)	Yes
Secondary	Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)		During study drug administration (6 to 24 hours)	Yes
Secondary	Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)		During study drug administration (6 to 24 hours)	Yes
Secondary	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)	Yes
Secondary	Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)		During study drug administration (6 to 24 hours)	Yes
Secondary	Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)		During study drug administration (6 to 24 hours)	Yes
Secondary	Time to Successful Extubation in DEX-exposed Subjects		From start of DEX administration to extubation of each subject up to 7 days post-infusion	Yes