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Neurally adjusted ventilatory assist (NAVA) is a new ventilator modality with an innovative synchronization technique. Our aim is to verify if NAVA is feasible and safe in terms of physiological and clinical variables in infants recovering from severe acute respiratory distress syndrome (ARDS). Design: This is a pilot nested study to help future trial design. Setting: The study was performed in third-level academic pediatric intensive care units. Patients: Infants affected by severe ARDS requiring high-frequency ventilation and weaned with NAVA during 2010 were included. Controls (2:1 ratio) were ARDS infants weaned with pressure support ventilation (PSV) during 2008-2009 matched for age, gas exchange impairment, and weight. Main outcome measures: The main outcome measures were the physiological and ventilator parameters and the duration of ventilator support in PSV or NAVA. Results: Ten infants treated with NAVA and 20 with PSV were studied. Heart rate (P b .001) and mean arterial pressure (P b .001) increased less during NAVA than during PSV. Similarly, PaO2/FIO2 ratio decreased less in NAVA than in PSV (P b .001). Neurally adjusted ventilatory assist also resulted in lower PaCO2 (P b .001) and peak pressure (P = .001), as well as higher minute ventilation (P = .013). COMFORT score (P = .004) and duration of support were lower in NAVA than in PSV (P = .011). Conclusions: Neurally adjusted ventilatory assist is safe and suitable in infants recovering from severe ARDS. It could provide better results than PSV and is worth to be investigated in a multicenter randomized trial. [ABSTRACT FROM AUTHOR]