Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Instituto Materno Infantil Prof. Fernando Figueira

Status: Completed

Conditions: Prematurity; Respiratory Distress Syndrome

Treatments: Device: nasal intermittent positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00821119

IMIP123

Details and patient eligibility

About

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)

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 1 to 1 day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infants with RDS
• assigned to non invasive ventilation

Exclusion criteria

• preterm on endotracheal ventilation
• severe congenital pulmonary or cardiovascular malformation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

NCPAP

Active Comparator group

Description:

preterm infants with nasal positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome will be compared to preterm infants with nasal intermittent positive pressure ventilation

Treatment:

Device: nasal intermittent positive pressure ventilation

NIPPV

Experimental group

Description:

preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome

Treatment:

Device: nasal intermittent positive pressure ventilation