Comparison of two weaning protocols in exremely and very preterm neonates with respiratory distress syndrome: a randomised, multicentre clinical trial

Abstract

BACKGROUND: The most common complication of prematurity is the newborn respiratory distress syndrome. It is a pathology that mainly affects premature infants born before 32 weeks of gestation. About 40% of these neonates require invasive mechanical ventilation to manage the syndrome. Recently, it has been recognised that reducing intubation time and the number of reintubations is of great significance in reducing further complications. Therefore, one approach to decrease complications is to identify a weaning protocol that facilitates posterior extubation. OBJECTIVE: The main objective is to compare the number of reintubations of pressure support ventilation and assist control volume guarantee ventilation, in extremely and very preterm neonates with newborn respiratory distress syndrome with invasive mechanical ventilation. DESIGN: This study is designed as a randomized, open label, multicentrical clinical trial. It will be conducted in 5 different hospitals of Catalonia. PARTICIPANTS: 542 participants will be enrolled from 5 hospitals using a stratified consecutive sampling, and the time of recruitment will be approximately of 2 years and two months. These patients will be randomized in two groups, one for each weaning protocol, with a 1:1 ratio