Abstract / Summary
Introduction: Severe pneumonia in term neonates frequently leads to acute respiratory failure requiring invasive mechanical ventilation. Point-of-care ultrasound (POCUS) can identify pulmonary consolidation at the bedside without ionising radiation, while chest physiotherapy (CPT) may help mobilise secretions and improve aeration. We aim to evaluate whether a nurse-performed POCUS-guided targeted CPT care pathway shortens the duration of invasive mechanical ventilation in term neonates with severe pneumonia.
Methods and analysis: This multicentre stepped-wedge cluster randomised trial will be conducted across three tertiary neonatal intensive care units (NICUs) over eight 3-month periods. All NICUs will begin in the control condition and then cross over sequentially to the intervention according to a randomised schedule. We plan to enrol 240 infants (approximately 80 per NICU). Eligible participants are term neonates with severe pneumonia, imaging-confirmed pulmonary consolidation and objectively defined respiratory failure requiring invasive mechanical ventilation. During intervention periods, trained bedside nurses will perform standardised lung POCUS every 8 hours and deliver targeted positioning and gentle percussion based on the ultrasound-determined location of consolidation. Control periods will involve standard care without routine nurse-performed lung POCUS; all CPT exposure will be recorded. The primary outcome is the duration of invasive mechanical ventilation among infants who survive to successful extubation. Analyses will use mixed-effects models with fixed effects for period and treatment and a random effect for cluster, supplemented by small-sample methods and prespecified covariate-adjusted and sensitivity analyses.
Ethics and dissemination: The study will be conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained from the Ethics Committee of Fujian Children's Hospital (ethics approval number 2026ETKLRK04008). Written informed consent will be obtained from parents or legal guardians before enrolment. Findings will be disseminated through peer-reviewed publication, conference presentation and feedback to participating clinical teams.
Trial registration number: ChiCTR2600123537.