NCT01159262

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 28 Weeks – 44 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Midazolam	Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
DRUG	Fentanyl/Morphine	Per package insert, N-PASS scores and investigator discretion.
DRUG	Dexmedetomidine

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-07-09
• Last updated: 2015-08-13
• Results posted: 2014-12-12

Locations

18 sites across 2 countries: United States, Guatemala