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Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01621373
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Adverse Reaction to Drug Neonatal Disorder Drug: propofol administration Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
propofol
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621373


Locations
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Belgium
Neonatal Intensive Care Unit UZ Leuven
Leuven, Vlaams brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
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Principal Investigator: Liesbeth Thewissen, MD UZ Leuven, Belgium
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT01621373    
Other Study ID Numbers: s54472
2012-002648-26 ( EudraCT Number )
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: August 2012
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
neonatology
intratracheal intubation
propofol
Additional relevant MeSH terms:
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Infant, Newborn, Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Propofol
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics