Cannula with long and narrow tubing versus short binasal prongs for nasal intermittent positive pressure ventilation in preterm infants with respiratory distress syndrome: a randomised non-inferiority trial.

OBJECTIVES: To determine whether nasal intermittent positive pressure ventilation (NIPPV) delivered via a cannula with long and narrow tubing (CLNT) was non-inferior to short binasal prongs (SBP) in preventing treatment failure among preterm infants with respiratory distress syndrome (RDS). DESIGN: Open-label, non-inferiority randomised controlled trial. SETTING: Level III neonatal unit. PATIENTS: Preterm infants (<34 weeks' gestation) requiring primary NIPPV support within 6 hours of birth for RDS. INTERVENTIONS: Infants were randomly assigned (1:1) to receive NIPPV via CLNT or SBP. MAIN OUTCOME MEASURES: The primary outcome was NIPPV failure requiring intubation within 72 hours of randomisation. The prespecified non-inferiority margin was an absolute risk difference of 10%. Secondary outcomes included nasal trauma, mortality and major neonatal morbidities. RESULTS: A total of 316 infants were randomised (158 per group). NIPPV failure occurred in 27 (17.1%) infants in the CLNT group and 23 (14.6%) in the SBP group (risk difference: 2.5%, 95% CI -5.51 to 10.56). Because the upper bound of the 95% CI exceeded the prespecified non-inferiority margin, non-inferiority was not demonstrated. Mortality, bronchopulmonary dysplasia, severe intraventricular haemorrhage, retinopathy of prematurity and duration of respiratory support were similar between groups. Nasal trauma was significantly lower with CLNT (any grade: 12.0% vs 44.9%, RR 0.27, 95% CI 0.17 to 0.42; moderate-to-severe: 4.4% vs 21.5%, RR 0.21, 95% CI 0.09 to 0.45). CONCLUSIONS: CLNT did not demonstrate non-inferiority to SBP according to the prespecified non-inferiority criterion for preventing treatment failure. Nevertheless, CLNT was associated with substantially lower rates of nasal trauma without evidence of increased short-term morbidity or mortality. REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2022/09/045914).