S K Samim1, Pradeep Kumar Debata2, Anita Yadav1, Jogender Kumar3, Pratima Anand1, Mehak Garg1. 1. Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029, India. 2. Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029, India. drpkdebata@gmail.com. 3. Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Abstract
To determine if RAM cannula is non-inferior to short binasal prongs (SBP) in providing nasal continuous positive airway pressure (CPAP) in preterm infants with respiratory distress syndrome (RDS). In this randomized, open-label, noninferiority trial from a low-middle-income country, we enrolled 254 preterm infants (28-34 weeks gestational age) with RDS who needed CPAP as primary respiratory support. The eligible infants were randomized to either RAM cannula or SBP interface groups. The primary outcome was CPAP failure (defined as the need for intubation or non-invasive positive pressure ventilation) within 72 h of randomization. The noninferiority margin was defined as a 10% or less absolute difference in CPAP failure rates. The secondary outcomes included nasal trauma and adverse events. We analyzed by per-protocol (primary) and intention to treat. CPAP failure has been seen in 25 infants (19.7%) in the RAM cannula group versus 22 (17.3%) in the SBP group (RD -2.36%; 95% CI -11.9 to 7.2 [beyond inferiority margin]; p = 0.6). Moderate and severe nasal trauma was less in RAM cannula (2.4 vs. 8.7%; RR 0.27; 95% CI 0.08-0.95; p 0.028). Duration of CPAP was also significantly shorter in the RAM cannula group (MD -12.4 h; 95% CI -20.34 to -4.46, p 0.017). There were no differences in other adverse events. CONCLUSIONS: RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome. TRIAL REGISTRATION: Registered at Clinical Trial Registry of India (CTRI/2020/03/024097). WHAT IS KNOWN: • RAM cannula is used for providing supplemental oxygen therapy. There is conflicting evidence on its efficacy in delivering CPAP support in preterm infants. WHAT IS NEW: • RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome. • RAM cannula causes less nasal trauma than short binasal prongs.
To determine if RAM cannula is non-inferior to short binasal prongs (SBP) in providing nasal continuous positive airway pressure (CPAP) in preterm infants with respiratory distress syndrome (RDS). In this randomized, open-label, noninferiority trial from a low-middle-income country, we enrolled 254 preterm infants (28-34 weeks gestational age) with RDS who needed CPAP as primary respiratory support. The eligible infants were randomized to either RAM cannula or SBP interface groups. The primary outcome was CPAP failure (defined as the need for intubation or non-invasive positive pressure ventilation) within 72 h of randomization. The noninferiority margin was defined as a 10% or less absolute difference in CPAP failure rates. The secondary outcomes included nasal trauma and adverse events. We analyzed by per-protocol (primary) and intention to treat. CPAP failure has been seen in 25 infants (19.7%) in the RAM cannula group versus 22 (17.3%) in the SBP group (RD -2.36%; 95% CI -11.9 to 7.2 [beyond inferiority margin]; p = 0.6). Moderate and severe nasal trauma was less in RAM cannula (2.4 vs. 8.7%; RR 0.27; 95% CI 0.08-0.95; p 0.028). Duration of CPAP was also significantly shorter in the RAM cannula group (MD -12.4 h; 95% CI -20.34 to -4.46, p 0.017). There were no differences in other adverse events. CONCLUSIONS: RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome. TRIAL REGISTRATION: Registered at Clinical Trial Registry of India (CTRI/2020/03/024097). WHAT IS KNOWN: • RAM cannula is used for providing supplemental oxygen therapy. There is conflicting evidence on its efficacy in delivering CPAP support in preterm infants. WHAT IS NEW: • RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome. • RAM cannula causes less nasal trauma than short binasal prongs.