Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation

Summary

Newborns admitted to an intensive care unit often require artificial ventilation. For that purpose an endotracheal tube needs to be placed into the trachea, a procedure named endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop moving and to relax in order to enable the success of the procedure. For this sedation an anesthetic agent named propofol is often used. The used dose of propofol has not been properly studied and as a consequence patients are under- or over -sedated and propofol leads to side effects such as hypotension.

The current study aims to find the most appropriate dose of propofol for newborns of different gestational ages and of different post-natal ages. We will use propofol in different doses and after each 5 included patients per age group we will analyze whether the dose needs to be increased or decreased. The effect of the propofol will be extensively monitored and we will study the level of sedation, the quality of intubation, the stability of the patient en the occurrence of side effects.

At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.

Conditions

• Anesthesia Intubation Complication
• Premature Birth of Newborn
• Other Preterm Infants
• Propofol Overdose

Interventions

DRUG

Propofol

Propofol, an anesthetic agent, is used to sedate the patients before endotracheal intubation. The propofol starting dose in all age groups will be 1.0 mg propofol/kg. After 5 patients per age group the next dose will be determined. Dose will be increased or decreased with 0.5 mg/kg for the next 5 patients. The study will be continued untill an adequate dose, that results in adequate sedation, good intubation conditions without hypotension, is determined. That dose will be valideted in another 5 patients per age group.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Maxima Medical Center

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Stichting Nuts Ohra

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Mirjam van Weissenbruch, MD PhD · VU Medical Center Amsterdam

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2018-01-23

Completion

2018-01-23

Countries

• Netherlands

Study Locations