This study was performed in accordance with the principles of the Declaration of Helsinki. Ethical approval was granted by the Institutional Review Board of the First Affiliated Hospital of Xiamen University (Approval No. [2025] KYLSZ (049)) prior to data collection. De-identified data extraction forms were used to maintain patient confidentiality. Given the retrospective nature of this study, the ethics committee waived the requirement for written informed consent.
Inclusion criteria. Neonates admitted to the facility between 2020 and 2024 were eligible for inclusion if they had a gestational age of ≥24 weeks, required non-invasive ventilation (NIV) within the first 72 h of life, and exhibited respiratory distress identified by clinical signs, including a respiratory rate >60 breaths/min, grunting, or a Silverman–Anderson score ≥3. The study intentionally included extremely preterm infants (24 weeks) and extremely low birth-weight infants (<1,000 g) to reflect the full clinical scope of NIV application.
Exclusion criteria. Infants with major craniofacial anomalies or those requiring immediate intubation were excluded.
1. Subject screening and preparation
The electronic medical database was searched for neonates admitted between 2020 and 2024 with a gestational age of ≥24 weeks who required non-invasive ventilation (NIV) within the first 72 hours of life. Respiratory distress was identified based on clinical signs, including a respiratory rate >60/min, grunting, or a Silverman–Anderson score ≥3. Infants with major craniofacial anomalies or those requiring immediate intubation were excluded. The inclusion of extremely preterm infants (24 weeks) and extremely low birth-weight infants (<1,000 g) was intentional to reflect the full clinical scope of NIV application in the unit.
2. Non-invasive ventilation interface application
The appropriate interface size was determined using a calibrated measuring guide to assess the nasal columellar distance and nostril diameter. The skin was cleaned and dried, followed by application of a thin hydrocolloid barrier. The barrier was cut into an ‘H-shape’ for nasal prongs or a ‘reverse heart-shape’ for nasal masks. The interface was then placed and secured with the fixation system, with Velcro straps adjusted to allow one finger-breadth of space to prevent excessive pressure.
Interface rotation was performed every 2–4 h for the alternating group. The timing within this interval was individualized based on clinical judgment and synchronized with routine clustered care to minimize unnecessary handling and physiological instability. This approach prioritized infant comfort, stability during handling, and the preservation of nasal skin integrity, as assessed at visual checkpoints.
During each interface switch, a 5-min pressure-relief period was provided by delivering oxygen via a low-flow cannula positioned 1–2 cm above the nares.
3. Visual checkpoints and monitoring
Visual checkpoints ensured that nasal prongs did not contact the base of the nose and that the nasal mask did not impinge on the eyes. Patients were monitored for clinical stabilization, including a reduction in respiratory rate and maintenance of oxygen saturation between 91%–95%. Blood gas samples were obtained at baseline and at 2, 6, 12, and 24 h after initiation to measure pH (potential of hydrogen), partial pressure of arterial oxygen (PaO₂), and partial pressure of arterial carbon dioxide (PaCO₂). Primary outcomes included NIV failure (intubation within 72 h) and nasal injury severity.
4. Post-procedural data analysis
All statistical analyses were performed after completion of clinical data collection to maintain procedural flow. Categorical and continuous variables were entered into statistical software for analysis. The normality of continuous data was assessed using the Shapiro–Wilk test. Clinical outcomes were compared across the three interface groups using ANOVA, the Kruskal–Wallis test, or the chi-square test, as appropriate. The Bonferroni correction was applied for multiple comparisons of secondary outcomes (blood gas parameters and inflammatory markers) to adjust the significance threshold. Multivariable logistic regression was used to identify independent predictors of nasal injury, adjusting for birth weight and CPAP duration.