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

• Status: Terminated
• Trial end date: 2018-01-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Maxima Medical Center; Stichting Nuts Ohra; VU University Medical Center; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Propofol

Criteria

Inclusion Criteria:

All neonates admitted to the two participating intensive care units:

• Less than 28 days postnatal age

• Who need endotracheal intubation

Exclusion Criteria:

Patients with:

• Major congenital anomalies or neurological disorders,

• Neonates with an abnormal upper airway,

• Those receiving continuous sedatives or opioids, and

• Those whose mothers received sedatives or opioids before or during delivery will be excluded during the first 2 days of life.