CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Midazolam +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01159262
NCT01159262Phase 3Completed
CompareCT.gov

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

Hospira, now a wholly owned subsidiary of Pfizer·interventional·Posted Jul 9, 2010·Updated Aug 13, 2015

In Brief

A Phase 3 clinical trial evaluating Midazolam, Fentanyl/Morphine, and 1 other intervention for Sedation. Completed, enrolled 36 participants across 18 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesGuatemala, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.0 years ago

Interventions

Midazolamdrug

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

Fentanyl/Morphinedrug

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

Dexmedetomidinedrug