An international multicenter randomized controlled trial of high frequency oscillation versus conventional mechanical ventilation in infants with congenital diaphragmatic hernia: the VICI-trial

INTERVENTION: After delivery, the patient will be intubated immediately and receive the allocated ventilation strategy (high‐frequency oscillatory ventilation or conventional ventilation). Vital functions will be measured by a monitor. General laboratory measurements, blood gasses and urine samples will be taken regularly according to the standard care on the intensive care unit. An arterial line and a central venous line will be given. X‐rays of the thorax will be made on a regular basis. To exclude a vitium cordis and to measure pulmonary hypertension, an echocardiography will be performed and repeated on clinical indication. An echo of the brain will be performed. After the patient has stabilized, surgery will be performed. If necessary, an ECMo procedure will be performed. All the procedures described above are standard procedures in paediatric intensive care medicine. Mostly, every child born with a congenital diaphragmatic hernia will undergo these procedures. CONDITION: ; Ventilation, Congenital diaphragmatic hernia, Neonates, Newborns, Bronchopulmonary dysplasia , High frequency oscillatory ventilation ; ; PRIMARY OUTCOME: Death at day 28 and/or oxygen dependency at day 28 SECONDARY OUTCOME: • Severity of chronic lung disease according to the Bancalari definition: ; ; o Determined in children having oxygen use at day 28 ; ; o Point of assessment of severity of chronic lung disease at day 56 or discharge whichever comes first: ; ; § Mild: breathing room air ; ; § Moderate: need for < 30 % oxygen ; ; § Severe: need for = 30 % oxygen and/or positive pressure by mechanical ventilation or CPAP ; ; ; • Number of ventilator‐free days at day 30 ; ; • Number of ventilator‐free days at day 60 ; INCLUSION CRITERIA: 1. Newborn children antenatally diagnosed with congenital diaphragmatic hernia 2. The children are born in one of the participating centres 3. The children are born at or after a gestational age of 34 weeks 4. Prenatal informed consent 5. High‐risk infants who received a fetal intervention may be included 6. Infants small for gestational age may be included