Reintubation Rate between Nasal High-Frequency Oscillatory Ventilation versus Synchronized Nasal Intermittent Positive Pressure Ventilation in Neonates: A Parallel Randomized Controlled Trial
Manapat Phatigomet, Anucha Apisarnthanarak, Gunlawadee Maneenil, Supaporn Dissaneevate, Waricha Janjindamai
Abstract
OBJECTIVE: Nasal high-frequency oscillatory ventilation (nHFOV) and synchronized nasal intermittent positive pressure ventilation (sNIPPV) were the new modes of noninvasive ventilation. This study's aim was to clarify as to which of the nHFOV and sNIPPV modes was superior in preventing postextubation failure or reintubation in neonates. STUDY DESIGN: An open-label parallel randomized study was performed. Extubated preterm and term neonates were randomly allocated into nHFOV or sNIPPV modes; the reintubation rate was evaluated within 7 days after extubation between the two modes. Subgroup analyses were performed for preterm (gestational age <37 weeks) and very preterm (gestational age <32 weeks) neonates. The sample calculation was 1,050 neonates; however, this trial was stopped early as enrollment was too slow. RESULTS: = 0.99), including preterm (nHFOV [4/55, 7%] vs. sNIPPV [3/44, 7%]) and very preterm (nHFOV [3/25, 12%] vs. sNIPPV [3/25, 12%]) neonates. CONCLUSION: After neonatal extubation, there was no significant difference of reintubation rates within 7 days between nHFOV and sNIPPV. This trial has been registered in the ClinicalTrials.gov database ( https://clinicaltrials.gov/ct2/show/NCT04323397 ). First posted registration on March 26, 2020. KEY POINTS: · There was no significant difference of reintubation rates between nHFOV and sNIPPV.. · During nHFOV support, one neonate developed pneumomediastinum.. · During sNIPPV support, one neonate developed pulmonary hemorrhage..