A three-group clinical trial comparing efficacy of continuous positive airway pressure (CPAP) by RAM cannula, nasal prongs and nasal mask in preterm neonates in NICU

Abstract

Introduction Continuous positive airway pressure (CPAP) is one of the most commonly used non-invasive respiratory support strategies for preterm neonates with respiratory distress syndrome (RDS). The choice of CPAP interface may influence both treatment success and interface-related complications, particularly nasal injury. This study aimed to compare the efficacy and safety of CPAP delivered via RAM cannula, nasal prongs, and nasal mask in preterm neonates admitted to the neonatal intensive care unit (NICU). Methods This randomized three-arm clinical trial was conducted on 90 preterm neonates admitted to the NICUs of selected hospitals affiliated with Isfahan University of Medical Sciences, Iran, between November and December 2022. A total of 104 neonates were assessed for eligibility; 14 were excluded (12 did not meet the inclusion criteria and 2 declined participation), and 90 eligible neonates were randomly assigned equally into three groups (n = 30 each): RAM cannula, nasal prongs, and nasal mask. Data were collected using a demographic information form, a researcher-developed CPAP efficacy checklist, and a neonatal nasal injury assessment checklist. The primary outcome was CPAP treatment success, and secondary outcomes included nasal injury and selected clinical effectiveness indicators. Data were analyzed using chi-square, one-way ANOVA, and multivariable logistic regression in SPSS version 16, with a significance level of P < 0.05. Results No statistically significant difference was observed in CPAP treatment success among the RAM cannula (80.0), nasal mask (86.7), and nasal prong (83.3) groups (P = 0.81). However, significant differences were observed in nasal injury scores among the three groups (P = 0.01). The RAM cannula group showed the lowest mean nasal injury score (1.87 ± 0.57), while the nasal prong group had the highest score (3.50 ± 1.33). The RAM cannula group also demonstrated significantly higher baseline respiratory distress scores, FiO2 requirements, PEEP levels, and longer CPAP duration (P < 0.05). Given the limited number of CPAP failure events, the multivariable logistic regression analysis should be considered exploratory. After adjustment for baseline respiratory severity, no statistically significant association was observed between CPAP interface type and treatment success. Conclusion RAM cannula, nasal mask, and nasal prongs showed comparable effectiveness in CPAP treatment success among preterm neonates. However, RAM cannula was associated with significantly lower nasal injury, suggesting a potential advantage in reducing interface-related complications. These findings should be interpreted cautiously due to the relatively small sample size and baseline differences in respiratory severity. Trial registration IRCT20230807059068N1). Copyright © 2026. Published by Elsevier Ltd.