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Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)

Primary Purpose

Adverse Reaction to Drug, Neonatal Disorder

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

propofol administration

About this trial

This is an interventional treatment trial for Adverse Reaction to Drug focused on measuring neonatology, intratracheal intubation, propofol

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Neonatal Intensive Care Unit UZ Leuven

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

propofol

Arm Description

All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01621373

First Posted

June 8, 2012

Last Updated

May 28, 2015

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01621373

Brief Title

Exploratory Propofol Dose Finding Study In Neonates

Acronym

NEOPROP

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 Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adverse Reaction to Drug, Neonatal Disorder

Keywords

neonatology, intratracheal intubation, propofol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propofol

Arm Type

Other

Arm Description

All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.

Intervention Type

Drug

Intervention Name(s)

propofol administration

Other Intervention Name(s)

Diprivan

Intervention Description

Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.

Primary Outcome Measure Information:

Title

Number of neonates where successful in- and extubation in INSURE conditions and successful intubation in non-INSURE conditions is achieved

Description

Time Frame

1 hour after propofol administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liesbeth Thewissen, MD

Organizational Affiliation

UZ Leuven, Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal Intensive Care Unit UZ Leuven

City

Leuven

State/Province

Vlaams brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

27597733

Citation

Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.

Results Reference

derived

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Exploratory Propofol Dose Finding Study In Neonates

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