Exploratory Propofol Dose Finding Study In Neonates

Phase 2 Completed 50 enrolled Universitaire Ziekenhuizen KU Leuven

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2012-08
Primary completion: 2014-07
Completion: 2014-07

Publications

Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Propofol	Small molecule	0.5 mg/kg	Intravenous
Subject	Propofol	Small molecule	1 mg/kg	Intravenous
Subject	Propofol	Small molecule	1.5 mg/kg	Intravenous

Indications

No indication recorded.