Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study

Introduction Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a promising respiratory support method for avoiding invasive mechanical ventilation in neonatal intensive care units (NICUs). However, its effectiveness and safety have not been widely established through clinical evidence. In this study, we aim to evaluate the feasibility of NIV-NAVA as a primary respiratory support method after birth and its effects on short-term clinical outcomes and long-term neurodevelopment in preterm infants.

Methods and analysis In this prospective multicentre observational study, 230 preterm infants will be recruited after birth. This study will include preterm infants born between 27+0 and 31+6 weeks of gestation who require respiratory support within the first 48 hours after birth. NIV-NAVA will be initiated as primary respiratory support either immediately after birth or during the early NICU stay, with settings adjusted according to each infant’s clinical condition. Discontinuation of NIV-NAVA or transition to continuous positive airway pressure or high-flow nasal cannula will be performed based on clinical stability. A less invasive surfactant administration method will be used for infants with respiratory distress syndrome to avoid intubation whenever possible. Infants intubated at birth will be extubated to NIV-NAVA as early as is clinically feasible. Invasive ventilation may be applied if clinical deterioration occurs. The rate of NIV-NAVA failure, duration of non-invasive and invasive ventilation, rate of bronchopulmonary dysplasia and clinical outcomes, such as air leak, patent ductus arteriosus, intraventricular haemorrhage and retinopathy of prematurity, will be measured. The neurodevelopmental outcomes of infants will be assessed for up to 3 years.

Ethics and dissemination The Institutional Review Board (IRB) of Korea University Anam Hospital (2024AN0554) and Seoul National University Bundang Hospital (IRB No. B-2507-984-304) approved this study. The results will be disseminated through scientific conferences and publications.

Trial registration number NCT06786039 registered on 14 January 2025.