Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial

Abstract Background Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with distress syndrome (RDS). However, NIV technique to be used first intention in RDS management not yet established. Nasal intermittent positive pressure (NIPPV) may synchronized (SNIPPV) or non-synchronized infant’s breathing efforts. The aim of study is evaluate short-term effects SNIPPV vs. NIPPV on cardiorespiratory events, trying identify modality at their approach support. Methods An unmasked randomized crossover three treatment phases was designed. All newborn < 32 weeks gestational age needing after extubation will consecutively enrolled and arm. After stabilization, patients alternatively ventilated two different techniques time frames 4 h each. administered same ventilator interface, maintaining continuous assisted without patient discomfort. During whole duration study, patient’s data from simultaneously recorded using a polygraph connected computer. primary outcome frequency episodes oxygen desaturation. Secondary outcomes are number FiO 2 necessity, pain score evaluation, synchronization index, thoracoabdominal asynchrony. calculated sample size 30 patients. Discussion It known that produces percentage ineffective acts due asynchronies between breaths. On other hand, an could increase work breathing. Our hypothesis efficient reduce volume per minute exchanged interfering natural rhythm RDS. results this allow us effectiveness synchronization, demonstrating whether most effective non-invasive mode ventilation. Trial registration ClinicalTrials.gov NCT03289936 . Registered September 21, 2017.