Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxyge
Recruiting
- Conditions
- eonatal respiratory insufficiency
- Registration Number
- NL-OMON26938
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 27
Inclusion Criteria
•Born between 24 weeks 0 days and 31 weeks and 6 days gestation.
•Receiving respiratory support (mechanical ventilation, HFO, NCPAP, NIPPV, or HFNC).
•Receiving supplemental oxygen (defined as FiO2 = 0.25) at the time of enrolment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of = 0.1 in the previous 24 hours.
•Expected to complete the 49-hour study period in the current form of respiratory support.
•A postnatal age of less than 36 weeks.
•Written informed parental consent.
Exclusion Criteria
•Major congenital anomalies
•Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of hypoxic episodes (SpO2 <80% for 1 second or longer)
- Secondary Outcome Measures
Name Time Method Time SpO2 spent in allocated target range, or above when set FiO2 <0.22.<br>Time SpO2 spent under 91%.<br>Time SpO2 spent in range 91%-96%, or above when set FiO2 <0.22.<br>Time SpO2 spent above 96% when set FiO2 >0.21.<br>Coefficient of variation of SpO2.<br>Time in hypoxaemic SpO2 ranges (SpO2 85%-90%, 80-84%, <80%).<br>Time in hyperoxaemic SpO2 ranges (SpO2 97%-98%, >98%) when set FiO2 >0.21.<br>Duration of hypoxaemic episodes (SpO2 <85% and <80%).<br>Frequency of hypoxaemic episodes (SpO2 <85% and <80%) for =30 seconds and =60 seconds.<br>Duration of hyperoxaemic episodes (SpO2 >96% and >98%) when set FiO2 >0.21.<br>Frequency of hyperoxaemic episodes (SpO2 >96% and >98%) for =30 seconds and =60 seconds when set FiO2 >0.21. <br>Frequency of bradycardic episodes (HR <100 bpm for =10 seconds).<br>Average oxygen exposure (average measured FiO2)<br>Coefficient of variation of FiO2<br>Frequency of SpO2 alarms on smartphone<br>Total duration of SpO2 alarms on smartphone