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Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)

This study has been completed.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: June 8, 2012
Last updated: May 28, 2015
Last verified: August 2012
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 Intervention Phase
Adverse Reaction to Drug
Neonatal Disorder
Drug: propofol administration
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.

Enrollment: 50
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01621373

Neonatal Intensive Care Unit UZ Leuven
Leuven, Vlaams brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Liesbeth Thewissen, MD UZ Leuven, Belgium
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01621373     History of Changes
Other Study ID Numbers: s54472
2012-002648-26 ( EudraCT Number )
Study First Received: June 8, 2012
Last Updated: May 28, 2015

Keywords provided by Universitaire Ziekenhuizen Leuven:
intratracheal intubation

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Infant, Newborn, Diseases
Chemically-Induced Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on April 27, 2017