Time spent within the SpO₂ target range during nasal CPAP therapy with different backup modes in extremely preterm...

To study the efficacy of different modes of backup nasal intermittent positive pressure ventilation (NIPPV) during nasal continuous positive airway pressure (nCPAP) therapy to keep extremely preterm (EPT) infants within the oxygen saturation (SpO₂) target range.

Single-centre randomised cross-over trial.

Level 3 neonatal intensive care unit.

24 EPT infants (median gestational age of 24+1 and median postnatal age of 43 days).

EPT infants on nCPAP therapy with backup NIPPV during apnoea >4 s were assigned in random sequence to immediate cessation of backup NIPPV or to stepwise reduction of backup NIPPV support on restart of spontaneous respiration.

Primary outcome was time spent within the SpO₂ target range (88%-95%). Secondary outcomes included frequency and duration of hypoxaemic and hyperoxaemic episodes, impact on cerebral tissue oxygenation, parameters of gas exchange and vital signs.

The mean percentage of time spent within the SpO₂ target range did not differ between immediate cessation of backup NIPPV on restart of spontaneous respiration compared with the stepwise reduction of backup NIPPV (61.1% vs 64.7%, p=0.15). There were no differences in the time spent below or above the SpO₂ target range, the number of prolonged (>30 s) and severe (<80% and <70%) desaturations and in the parameters of cerebral tissue oxygenation. The stepwise reduction of backup NIPPV resulted in a significant increase in mean airway pressure (7.2 cm H₂0 vs 5.6 cm H₂0, p<0.01) and reduction in respiratory frequency (60.1 vs 63.8, p=0.02) compared with the immediate cessation of backup NIPPV on restart of spontaneous respiration, while mean fraction of inspired oxygen, transcutaneous carbon dioxide pressure and heart rate did not vary between the two interventions.

Our findings underpin that new sophisticated ventilation modes like stepwise reduction of backup NIPPV do not necessarily provide a clinical benefit compared with the standard mode. For this, technological advances require robust evaluation within well-designed clinical trials demonstrating the safety and efficacy before being used in everyday clinical practice.

German Clinical Trials Register; registration number: DRKS00031956 (https://drks.de/search/en/trial/DRKS00031956), date of registration: 26 May 2023.