- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01621373
Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Vlaams brabant
-
Leuven, Vlaams brabant, Belgium, 3000
- Neonatal Intensive Care Unit UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: propofol
All patients receive propofol.
Dose will be defined based on response of previous patient in the same stratum.
|
Single IV bolus propofol start at 1 mg/kg.
Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour after propofol administration
|
Collaborators and Investigators
Investigators
- Principal Investigator: Liesbeth Thewissen, MD, UZ Leuven, Belgium
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- s54472
- 2012-002648-26 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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