Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Prematurity, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: nasal intermittent positive pressure ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants with RDS assigned to non invasive ventilation Exclusion Criteria: preterm on endotracheal ventilation severe congenital pulmonary or cardiovascular malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NCPAP<br>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 | Device: nasal intermittent positive pressure ventilation<br>* 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<br>* Other names: NIPPV;|
| Experimental: NIPPV<br>preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome | Device: nasal intermittent positive pressure ventilation<br>* 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<br>* Other names: NIPPV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Endotracheal Ventilation in the First 72 hs of Life | number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life | first 72 hs of life | 
| Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) | 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 | first 3 days of life(72hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary Dysplasia | 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. | at 36 weeks gestational age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non invasive ventilation, mechanical ventilation, pulmonary morbidity, preterm infant, Respiratory distress syndrome, nasal intermittent positive pressure, nasal continuous positive pressure, bronchopulmonary dysplasia