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Open Access Highly Accessed Study protocol

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

Lieke van den Hout1, Dick Tibboel1, Sanne Vijfhuize1, Harma te Beest1, Wim Hop2, Irwin Reiss1* and The CDH-EURO Consortium

Author Affiliations

1 Intensive care and Department of Pediatric Surgery, Erasmus MC - Sophia, Dr. Molewaterplein 50, 3015 GE, Rotterdam, the Netherlands

2 Department of biostatistics, ErasmusMC, Dr. Molewaterplein 50, 3015 GE, Rotterdam, the Netherlands

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BMC Pediatrics 2011, 11:98  doi:10.1186/1471-2431-11-98

Published: 2 November 2011

Abstract

Background

Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH.

Methods/design

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.

Discussion

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.

Trial registration

Netherlands Trial Register (NTR): NTR1310