Continuous positive airway pressure versus conventional oxygen therapy in meconium aspiration syndrome: a randomized controlled trial

Abstract Neonates with meconium aspiration syndrome (MAS) frequently require respiratory support. However, the initial mode of respiratory support in these patients remains unclear. We aimed to assess whether early nasal continuous positive airway pressure (nCPAP), compared to conventional oxygen therapy, reduces the need for invasive mechanical ventilation (IMV) in neonates with MAS. In this open-label randomized controlled trial, neonates born at >34 weeks of gestation who developed mild to moderate respiratory distress within the first 24 hours were randomly allocated to the nCPAP or oxygen hood (5–10 l/min) group. The primary outcome was the need for intubation and IMV during the first 72 hours of life. The secondary outcomes included all-cause mortality before discharge, air leaks, sepsis, pulmonary hypertension, duration of respiratory support, and hospital stay. We analyzed the data using the intention-to-treat method. Eighty neonates (40 in each group) were enrolled. There was no statistically significant difference in the need for IMV between the nCPAP and oxygen hood groups (4 [10%] vs. 5 [12.5%]; relative risk, 0.80; 95% CI: 0.23–2.76). Primary respiratory support failure rates, mortality, pulmonary hypertension, and other outcomes were comparable between the groups. In this trial, nCPAP therapy was not superior to conventional oxygen therapy for the treatment of mild to moderate MAS. Trial registration Clinical Trial Registry of India (CRTI/2020/02/023529)