NCT00368680

Early CPAP in Respiratory Distress Syndrome

Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 5 Minutes – 30 Minutes
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

Detailed description

The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation. Hypothesis: \- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy. The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. . As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age. Comparison(s): Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	Early Bubble CPAP

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2009-09-01
• First posted: 2006-08-25
• Last updated: 2010-12-24

Locations

14 sites across 5 countries: Argentina, Chile, Paraguay, Peru, Uruguay