At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
propofol administrationdrug
Likely dose
propofol administration 1 mg/kgfrom 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.
Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates
In Brief
A Phase 2 clinical trial evaluating propofol administration for Adverse Reaction to Drug and Neonatal Disorder. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Reaction to Drug, Neonatal Disorder
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartAug 2012
Primary CompletionJul 2014
TodayJul 2026
First PostedJun 18, 2012
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.0 years ago
Interventions
propofol administrationdrug
Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.