Overview

Exploratory Propofol Dose Finding Study In Neonates

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universitaire Ziekenhuizen Leuven
Treatments:
Propofol
Criteria
Inclusion Criteria:

- Neonates admitted to the Neonatal Intensive Care Unit who need short procedural
sedation for (semi-) elective intubation will be considered for inclusion, after
informed written consent of the parents.

- Patients can be included if they are hemodynamically stable and did not receive
sedative or analgesic agents during the previous 24 hours.

Exclusion Criteria:

- Known propofol intolerance