An international multicenter randomized controlled trial of high frequency oscillation versus conventional mechanical ventilation in infants with congenital diaphragmatic hernia: the VICI-trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- congenital diaphragmatic hernia/congenitale hernia diafragmatica/ventilation/beademing/neonates/neonaten/newborns/pasgeborenen/chronic lung disease/ bronchopulmonary dysplasia/ bronchopulmonaire dysplasie/high frequency oscillatory ventilation
- Sponsor
- ErasmusMC-SophiaP.O. Box 20603000 CB Rotterdamthe Netherlands
- Enrollment
- 400
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
-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.
-Logan, J.W., et al., Mechanical ventilation strategies in the management of congenital diaphragmatic hernia. Semin Pediatr Surg, 2007. 16(2): p. 115-25.
-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.
-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.
-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.
-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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Newborn children antenatally diagnosed with congenital diaphragmatic hernia
- •2\. The children are born in one of the participating centres
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified