An international multicenter randomized controlled trial of high frequency oscillation versus conventional mechanical ventilation in infants with congenital diaphragmatic hernia: the VICI-trial
- Conditions
- congenital diaphragmatic hernia/congenitale hernia diafragmatica/ventilation/beademing/neonates/neonaten/newborns/pasgeborenen/chronic lung disease/ bronchopulmonary dysplasia/ bronchopulmonaire dysplasie/high frequency oscillatory ventilation
- Registration Number
- NL-OMON23312
- Lead Sponsor
- ErasmusMC-SophiaP.O. Box 20603000 CB Rotterdamthe Netherlands
- Brief Summary
Migliazza, L., et al., Retrospective study of 111 cases of congenital diaphragmatic hernia treated with early high-frequency oscillatory ventilation and presurgical stabilization. J Pediatr Surg, 2007. 42(9): p. 1526-32. <br> -Ng, G.Y., et al., Reduction in ventilator-induced lung injury improves outcome in congenital diaphragmatic hernia? Pediatr Surg Int, 2008. 24(2): p. 145-150.<br> -Logan, J.W., et al., Mechanical ventilation strategies in the management of congenital diaphragmatic hernia. Semin Pediatr Surg, 2007. 16(2): p. 115-25.<br> -Cacciari, A., et al., High-frequency oscillatory ventilation versus conventional mechanical ventilation in congenital diaphragmatic hernia. Eur J Pediatr Surg, 2001. 11(1): p. 3-7.<br> -Bhuta, T., R.H. Clark, and D.J. Henderson-Smart, Rescue high frequency oscillatory ventilation vs conventional ventilation for infants with severe pulmonary dysfunction born at or near term. Cochrane Database Syst Rev, 2001(1): p. CD002974.<br> -Henderson-Smart, D.J., et al., Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants. Cochrane Database Syst Rev, 2007(3): p. CD000104.<br> -Clark, R.H., et al., Lung injury in neonates: causes, strategies for prevention, and long-term consequences. J Pediatr, 2001. 139(4): p. 478-86.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
1. Newborn children antenatally diagnosed with congenital diaphragmatic hernia
2. The children are born in one of the participating centres
1. Infants born with a severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop further life-saving medical treatment
2. Infants born with a severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death at day 28 and/or oxygen dependency at day 28
- Secondary Outcome Measures
Name Time Method • Severity of chronic lung disease according to the Bancalari definition: <br /><br> oDetermined in children having oxygen use at day 28<br /><br> oPoint of assessment of severity of chronic lung disease at day 56 or discharge whichever comes first:<br /><br> §Mild: breathing room air<br /><br> §Moderate: need for < 30 % oxygen<br /><br> §Severe: need for ≥ 30 % oxygen and/or positive pressure by mechanical ventilation or CPAP<br><br /><br>• Number of ventilator-free days at day 30<br /><br>• Number of ventilator-free days at day 60<br>