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

High frequency oscillatory ventilation is an effective way of providing gas exchange. In animals with severe pulmonary disease, high frequency oscillatory ventilation improves gas exchange, promotes uniform lung inflation, reduces barotrauma and decreases the appearance of inflammatory mediators. Also, high frequency oscillatory ventilation may reduce the severity of lung injury induced by mechanical ventilation.
High frequency oscillatory ventilation has been used in preterm infants with respiratory distress syndrome, either as an elective ventilation strategy or as a rescue therapy when conventional ventilation failed. A Cochrane review, which described the use of elective high frequency oscillatory ventilation compared to conventional ventilation in preterm infants, found no significant differences in mortality and oxygen therapy. Some trials, however, described a significant reduction of chronic lung disease in preterm infants treated with high frequency oscillatory ventilation. A second Cochrane review described the use of high frequency oscillatory ventilation as a rescue therapy when conventional ventilation failed in term and near term infants. Only one trial compared these two ventilation strategies in a prospective way, resulting in no significant difference in outcome, need for extracorporeal membrane oxygenation, or complications.
In children having congenital diaphragmatic hernia the use of high frequency oscillatory ventilation and conventional ventilation have been compared retrospectively. Studies showed significantly improved survival and a lower incidence of chronic lung disease with elective use of high frequency oscillatory ventilation. However, these studies investigated the ventilation strategies in different eras. Therefore, the results might be positively influenced by other medical improvements during the last decades. Other retrospective descriptive studies concluded high frequency oscillatory ventilation to be a safe ventilation strategy in infants having congenital diaphragmatic hernia.
No prospective randomized controlled trials have been carried out to compare high frequency oscillatory ventilation to conventional ventilation in infants having congenital diaphragmatic hernia. Therefore, a future trial to give a more clear description of the effects of high frequency oscillatory ventilation in children having congenital diaphragmatic hernia is needed.

Does treatment with high frequency oscillatory ventilation reduce the incidence of chronic lung disease at day 28 and/or death at day 28 in comparison with conventional mechanical ventilation in new-born children having congenital diaphragmatic hernia ?

- Antenatal screening period, prior to enrollment

- Randomization period, within one hour after birth

- Treatment period, depending on cardio respiratory status of the infant

- Observation period, up to day 56 after birth or discharge

- Follow-up period during the first year of life

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.