O-223 The Vici-trial: An International Multicenter Randomised Clinical Trial Comparing Hfo And Cmv As Initial Ventilation Strategy In Congenital Diaphragmatic Hernia

Background Congenital diaphragmatic hernia (CDH) is a life-threatening anomaly with significant mortality and morbidity. The lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of chronic lung disease (CLD). Aim To establish the optimal initial ventilation strategy in CDH. Methods In a prospective, randomised international multicenter trial initiated by the CDH Euroconsortium (VICI-trial, NTR 1310), prenatally diagnosed CDH neonates born between November 2008 and December 2013, were randomised for either conventional mechanical ventilation (CMV) or high-frequency oscillation ventilation (HFO) as initial ventilation mode. Primary outcome measure was death or CLD (Jobe and Bancalari, 2001) at day 28 analysed by multiple logistic regression analysis corrected for centre, lung-to-head ratio, liver position and side of defect. Secondary outcome was corrected for centre. Results Of the 171 included patients, 91 (53.2%) initially received CMV (median gestational age 38.1 weeks) and 80 (46.8%) HFO (median gestational age 38.0 weeks). In total, 21 (23.1%) patients ventilated by CMV died and 25 (31.3%) in HFO. Of the survivors, 21 (23.1%) had CLD in CMV and 18 (22.5%) in HFO. Primary outcome measure showed that in CMV 41 (45.1%) died or had CLD at day 28 and in HFO 43 (53.8%), OR 0.6, 95% CI [0.12–2.54]. Results of secondary outcome are shown in Table 1. Conclusions Although the primary outcome was statistically not significant, CDH patients initially ventilated by CMV were ventilated less days, received inotropics less days, and received less often nitric oxide, sildenafil and ECMO compared to HFO.