NCT00821119

Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira · Academic / Other
• Sex: All
• Age: 1 Day – 1 Day
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)

Detailed description

Respiratory distress syndrome(RDS) and its sequelae, bronchopulmonary dysplasia(BPD) are complications of prematurity.The pathogenesis of BPD is multifactorial and one of the most important risk factors is the ventilator-induced lung injury caused by invasive respiratory support. The two modes of non-invasive ventilation, NIPP and specially NCPAP, have been used frequently in the respiratory care of preterm infants in neonatal units.NCPAP is currently a common practice for the treatment of RDS . NIPP has been found to be more effective than NCPAP in apnea of prematurity and immediately after extubation in preterm infants,decreasing the need of endotracheal ventilation. Alternative techniques of non-invasive ventilation has been suggested in some studies to decrease respiratory morbidities associated with prematurity.This non-invasive approach could be used initially as a primary mode of ventilation for infants with RDS in a effort to decrease lung injury and BPD.Studies are needed to compare the effectiveness of these therapies.

Conditions

• Prematurity
• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	nasal intermittent positive pressure ventilation	Nasal intermittent positive airway pressure will be compared are the nasal continuous positive pressure as an initial ventilatory mode in preterm infants with respiratory distress syndrome

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2009-01-13
• Last updated: 2013-03-12
• Results posted: 2013-02-11

Locations

2 sites across 1 country: Brazil