Exploratory Propofol Dose Finding Study In Neonates

Adverse Reaction to Drug Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621373
• Other study ID #: s54472
• Secondary ID: 2012-002648-26
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: May 28, 2015
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Drug-Related Side Effects and Adverse Reactions
• Infant, Newborn, Diseases
• Neonatal Disorder

Intervention

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.

Locations

Country	Name	City	State
Belgium	Neonatal Intensive Care Unit UZ Leuven	Leuven	Vlaams brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No