Optimizing propofol dosing for (preterm) newborn infants that need endotracheal intubatio
Completed
- Conditions
- sedatie bij verrichtingsedation
- Registration Number
- NL-OMON45172
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 91
Inclusion Criteria
All neonates admitted to the 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: Primary outcome is the appropriate dose of<br /><br>propofol in 8 different age groups. Optimized propofol doses need to be related<br /><br>with adequate sedation, good quality of intubation conditions and no short term<br /><br>side effects. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include further evaluation of cerebral perfusion, stress<br /><br>levels and short and long term outcome of the included patients. The<br /><br>incorporation of PK data and genotype of patients is used to make a prediction<br /><br>model for future patients that includes various important cofactors, related to<br /><br>effects and side effects of propofol. Physiological and behavioural responses<br /><br>of the newborns are further explored to find the most reliable and validate<br /><br>neonatal sedation score for intubations. </p><br>