Exploratory Propofol Dose Finding Study In Neonates

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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

Conditions
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Adverse Reaction to Drug, Neonatal Disorder

Intervention / Treatment
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* Drug: propofol administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: propofol<br>All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. | Drug: propofol administration<br>* Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.<br>* Other names: Diprivan;|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatology, intratracheal intubation, propofol