title: Conventional Mechanical Ventilation Versus High-frequency Oscillatory Ventilation for Congenital Diaphragmatic Hernia: A Randomized Clinical Trial (The VICI-trial).
abstract: OBJECTIVE
  To determine the optimal initial ventilation mode in congenital diaphragmatic hernia.
  
  
  BACKGROUND
  Congenital diaphragmatic hernia is a life-threatening anomaly with significant mortality and morbidity. The maldeveloped lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of bronchopulmonary dysplasia (BPD) and chronic respiratory morbidity.
  
  
  METHODS
  An international, multicenter study (NTR 1310), the VICI-trial was performed in prenatally diagnosed congenital diaphragmatic hernia infants (n = 171) born between November 2008 and December 2013, who were randomized for initial ventilation strategy.
  
  
  RESULTS
  Ninety-one (53.2%) patients initially received conventional mechanical ventilation and 80 (46.8%) high-frequency oscillation. Forty-one patients (45.1%) randomized to conventional mechanical ventilation died/ had BPD compared with 43 patients (53.8%) in the high-frequency oscillation group. An odds ratio of 0.62 [95% confidence interval (95% CI) 0.25-1.55] (P = 0.31) for death/BPD for conventional mechanical ventilation vs high-frequency oscillation was demonstrated, after adjustment for center, head-lung ratio, side of the defect, and liver position. Patients initially ventilated by conventional mechanical ventilation were ventilated for fewer days (P = 0.03), less often needed extracorporeal membrane oxygenation support (P = 0.007), inhaled nitric oxide (P = 0.045), sildenafil (P = 0.004), had a shorter duration of vasoactive drugs (P = 0.02), and less often failed treatment (P = 0.01) as compared with infants initially ventilated by high-frequency oscillation.
  
  
  CONCLUSIONS
  Our results show no statistically significant difference in the combined outcome of mortality or BPD between the 2 ventilation groups in prenatally diagnosed congenital diaphragmatic hernia infants. Other outcomes, including shorter ventilation time and lesser need of extracorporeal membrane oxygenation, favored conventional ventilation.
authors.affiliation: *Intensive Care and Department of Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, The Netherlands †Department of Medical and Surgical Neonatology, Bambino Gesù Hospital, Rome, Italy ‡Department of Biostatistics, Erasmus Medical Centre, Rotterdam, The Netherlands §Division of Asthma, Allergy and Lung Biology, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, London, UK.
authors.forename: Kitty G
authors.initials: KG
authors.lastname: Snoek
authors.forename: Irma
authors.initials: I
authors.lastname: Capolupo
authors.forename: Joost
authors.initials: J
authors.lastname: van Rosmalen
authors.forename: Lieke de Jongste-van den
authors.initials: Lde J
authors.lastname: Hout
authors.forename: Sanne
authors.initials: S
authors.lastname: Vijfhuize
authors.forename: Anne
authors.initials: A
authors.lastname: Greenough
authors.forename: René M
authors.initials: RM
authors.lastname: Wijnen
authors.forename: Dick
authors.initials: D
authors.lastname: Tibboel
authors.forename: Irwin K M
authors.initials: IK
authors.lastname: Reiss
mesh_terms: D015199:Extracorporeal Membrane Oxygenation; D005260:Female; D065630:Hernias, Diaphragmatic, Congenital / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006612:High-Frequency Ventilation; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011296:Prenatal Diagnosis; D011446:Prospective Studies; D012121:Respiration, Artificial / Q000379:methods*; D015996:Survival Rate; D016896:Treatment Outcome