title: The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR1310.
authors: Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia, Dr. Molewaterplein 50, Rotterdam, the Netherlands.
authors: Lieke
authors: L
authors: van den Hout
authors: Dick
authors: D
authors: Tibboel
authors: Sanne
authors: S
authors: Vijfhuize
authors: Harma
authors: H
authors: te Beest
authors: Wim
authors: W
authors: Hop
authors: Irwin
authors: I
authors: Reiss
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006548:Hernia, Diaphragmatic / Q000150:complications / Q000401:mortality / Q000628:therapy; D065630:Hernias, Diaphragmatic, Congenital; D006612:High-Frequency Ventilation / Q000379:methods*; D006801:Humans; D007226:Infant Mortality / Q000639:trends; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies; D012127:Respiratory Distress Syndrome, Newborn / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome