A gentler NIPPV cannula missed noninferiority by 0.56 percentage points

In 316 preterm infants, 72-hour NIPPV failure occurred in 27/158 with a long, narrow cannula versus 23/158 with short binasal prongs. The 95% CI crossed the 10-point noninferiority margin by 0.56 points, while any nasal trauma fell from 44.9% to 12.0%. Gentler is credible; equivalent efficacy is not established.

THE HOT TAKE

A large reduction in nasal trauma cannot erase a failed efficacy boundary. The failed boundary also does not prove inferiority.

A new open-label noninferiority trial randomized 316 infants born before 34 weeks in one level III neonatal unit. All required primary NIPPV within 6 hours of birth for respiratory distress syndrome. The PubMed record identifies the trial as CTRI/2022/09/045914. Infants received either a cannula with long and narrow tubing or short binasal prongs, with 158 assigned to each group.