Newborn respiratory distress syndrome Breathing problems in newborn babies
Conditions
Interventions
Automated control of the FiO2 based on the measured SpO2 for 72 hours.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Admitted to the NICU in the Erasmus MC, Rotterdam- Gestational age <37 weeks.- Receiving respiratory support (invasive, non-invasive or high flow) and a FiO2 of > 21%.- Written informed parental informed c
Exclusion criteria
Exclusion criteria: Congenital or chromosomal defects.- Transfer of the patient within 24 hours- Expected switch of ventilation mode (invasive to non invasive, non-invasive to high flow) within 72 hours- Patients on High Frequency Oscillation- Patients receiving Nitrous Oxide (NO) therapy.- Suspicion of NEC- Planned surgery within 4 days of start study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the study is to determine, what is the best algorithm (Day 1:Manual oxygen control, Day 2: Closed-loop oxygen control), defined as the algorithm with the lowest area outside of the patient Spo2 target range? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are among others the time spend within the target range, the number of hyper and hypoxic events, average maximum and minimum SpO2 during these events, number of FiO2 adjustments (manual and automated) and cerebral oxygen saturation when available. | — |
Countries
Netherlands
Contacts
Public ContactJ.J Wisse- Smit
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed