Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)
|ClinicalTrials.gov Identifier: NCT01621373|
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adverse Reaction to Drug Neonatal Disorder||Drug: propofol administration||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621373
|Neonatal Intensive Care Unit UZ Leuven|
|Leuven, Vlaams brabant, Belgium, 3000|
|Principal Investigator:||Liesbeth Thewissen, MD||UZ Leuven, Belgium|