Neonatal respiratory insufficiency
Conditions
Interventions
Interventional target range: OxyGenie automated oxygen controller set to target an SpO2 of 92%-96% for 25 hours, including a 1 hour wash-out period after a change in set target range.
Standard target
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
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
Exclusion criteria: • Major congenital anomalies • Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrolment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time SpO2 spent in allocated target range, or above when set FiO2 0.21. Coefficient of variation of SpO2. Time in hypoxaemic SpO2 ranges (SpO2 85%-90%, 80-84%, 98%) when set FiO2 >0.21. Duration of hypoxaemic episodes (SpO2 96% and >98%) when set FiO2 >0.21. Frequency of hyperoxaemic episodes (SpO2 >96% and >98%) for =30 seconds and =60 seconds when set FiO2 >0.21. Frequency of bradycardic episodes (HR <100 bpm for =10 seconds). Average oxygen exposure (average measured FiO2) Coefficient of variation of FiO2 Frequency of SpO2 alarms on smartphone Total duration of SpO2 alarms on smartphone | — |
Primary
| Measure | Time frame |
|---|---|
| Frequency of hypoxic episodes (SpO2 <80% for 1 second or longer) | — |
Contacts
Public ContactHylke Salverda
Leiden University Medical Center
Outcome results
None listed