The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial

This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension.To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity.Netherlands Trial Register (NTR): NTR1310Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm, which occurs in approximately one in 3000 live births [1]. In CDH, the diaphragmatic defect allows abdominal organs to herniate into the chest cavity. As a consequence, underdevelopment of the lungs and abnormal pulmonary vasculature growth may occur, resulting in pulmonary hypoplasia and pulmonary hypertension [2,3].Children with CDH mostly present with immediate cardiorespiratory distress during the first hours of life. The initial therapy for these children is mechanical ventilation and cardiorespiratory stabilization in support of optimal management of the pulmonary hypoplasia and pulmonary hypertension [4]. Thereafter, surgical repair of the diaphragmatic defect is indicated [4]. Although many advances in treatment for CDH patients have been made throughout the years, CDH remains a life-threatening condition with a reported mortality of 20-70%, dependin