Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)
July 29, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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
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).
Study Overview
Status
Completed
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.
Intubation condition score was assessed retrospectively by the intubating physician.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- Neonatal Intensive Care Unit UZ Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 4 weeks (Child)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|---|
|
Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
Time Frame: 1 hour after propofol administration
|
An up-and-down dose-response design was used to calculate ED50 (mg/kg) in strata with effective sampling size of at least 6, by use of the Dixon-Massey method for small samples.
|
1 hour after propofol administration
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation Condition Score
Time Frame: After final intubation.
|
Intubation condition score at final intubation was assessed retrospectively by the intubating physician.
The score as described by Viby-Mogensen was used, with the evaluation of laryngoscopy, vocal cords, coughing, jaw relaxation and limb movements.
The minimum score of the intubation condition score is 5, the maximum score of the intubation condition score is 20.
A score less or equal to 10 defines a good intubation condition.
|
After final intubation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liesbeth Thewissen, MD, UZ Leuven, Belgium
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 13, 2012
First Posted (Estimated)
June 18, 2012
Study Record Updates
Last Update Posted (Actual)
July 30, 2024
Last Update Submitted That Met QC Criteria
July 29, 2024
Last Verified
August 1, 2012
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.