Ram cannula vs nasal mask interface for providing CPAP in preterm neonates (< 34 weeks) with respiratory distress syndrome in a low- and middle-income country: an open-label, non-inferiority randomized controlled trial.

Abstract / Summary

The present open-label, non-inferiority randomized controlled trial aimed to determine the efficacy and safety of RAM cannula as compared to nasal mask on the need for mechanical ventilation within 72 h of initiation of nCPAP. Preterm neonates (< 34 weeks) with Silverman-Anderson Score ≥ 3/10 were allocated to either RAM cannula or nasal mask for providing nCPAP. Two hundred and ten neonates were enrolled in the study, 105 each in the RAM cannula group and nasal mask group, respectively. Baseline characteristics were similar between the two groups. The proportion of neonates who needed mechanical ventilation within 72 h of initiation of nCPAP support allocated to the RAM cannula group and nasal mask group were 22 (21%) and 13 (12%), respectively (risk difference 8.57%, 95% CI -1.44 to 18.59). The non-inferiority of RAM cannula could not be established as the upper bound of 95% CI crossed the pre-specified non-inferiority margin of 15%. Other clinical parameters like incidence and severity of nasal injury, duration of CPAP support, mortality, and common neonatal morbidities were comparable. RAM cannula is not non inferior as compared to nasal mask in reducing the need for mechanical ventilation within 72 h of initiation of CPAP support in preterm neonates (< 34 weeks) with RDS.   www.ctri.nic.in , id CTRI/2024/06/068826, registered on 12/06/2024. • RAM cannula is not non-inferior to short binasal prongs (SBP) in providing CPAP to preterm infants with RDS. • RAM cannula causes less nasal trauma than SBP. • RAM cannula is not non-inferior as compared to nasal mask in reducing the need for mechanical ventilation within 72 h of initation of CPAP support in preterm neonates (< 34 weeks) with RDS. • The incidence of nasal injury is comparable between RAM cannula and nasal mask.

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