Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
NIPPV	nasal intermittent positive pressure ventilation	preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome
NCPAP	nasal intermittent positive pressure ventilation	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

Primary Outcome Measures

Name	Time	Method
Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)	first 3 days of life(72hours)	The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit
Need for Endotracheal Ventilation in the First 72 hs of Life	first 72 hs of life	number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life

Secondary Outcome Measures

Name	Time	Method
Bronchopulmonary Dysplasia	at 36 weeks gestational age	The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.

Locations (2): Maternal Infant Institute Prof Fernando Figueira
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Recife, Pernambuco, Brazil
Instituto materno Infantil Fernando Figueira
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Recife, Pernambuco, Brazil