Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)
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).
Adverse Reaction to Drug
Drug: propofol administration
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of neonates where successful in- and extubation in INSURE conditions and successful intubation in non-INSURE conditions is achieved [ Time Frame: 1 hour after propofol administration ] [ Designated as safety issue: No ]Using predefined scoring systems we will evaluate in how many patients successful intubation and extubation in INSURE-conditions was achieved. In non-INSURE conditions only successful intubation will be evaluated. Afterward we will explore the given dose of propofol in each stratum to reach this outcome measure.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.
Drug: propofol administration
Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Other Name: Diprivan
The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous bolus. This is part of routine clinical care in patients receiving (semi-) elective intubation. It's the aim to explore the most effective IV propofol dose for a successful INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen for propofol in neonates.
we will hereby use
- predefined scoring systems to evaluate sedation, relaxation and intubation conditions
- vital parameter monitoring
- pharmacokinetic analysis with blood samples
- brain monitoring with NIRS (Near infrared spectroscopy) derived cerebral oxygenation and aEEG (amplitude integrated EEG).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621373
|Contact: Liesbeth Thewissen, MD||+3216343211||Liesbeth.firstname.lastname@example.org|
|Contact: Anne Smits, MD||+3216343211||Anne.email@example.com|
|Neonatal Intensive Care Unit UZ Leuven||Recruiting|
|Leuven, Vlaams brabant, Belgium, 3000|
|Contact: Liesbeth Thewissen, MD +3216343211 Liesbeth.firstname.lastname@example.org|
|Contact: Anne Smits, MD +3216343211 email@example.com|
|Principal Investigator:||Liesbeth Thewissen, MD||UZ Leuven, Belgium|