Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Instituto Materno Infantil Prof. Fernando Figueira |
---|---|
Information provided by: | Instituto Materno Infantil Prof. Fernando Figueira |
ClinicalTrials.gov Identifier: | NCT00821119 |
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)
Condition | Intervention |
---|---|
Prematurity Respiratory Distress Syndrome |
Device: non invasive ventilation (NCPAP) Device: non-invasive ventilation (NIPP) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 - NCPAP: Active Comparator
preterm infants with nasal continuous positive pressure as the mode of respiratory support
|
Device: non invasive ventilation (NCPAP)
Nasal continuous positive airway pressure. The types of non invasive ventilation that will be compared are the nasal continuous positive pressure versus the nasal intermittent positive pressure ventilation. |
2- NIPP: Active Comparator
preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
|
Device: non-invasive ventilation (NIPP)
Nasal intermittent positive pressure. The types of non invasive ventilation that will be compared are the nasal continuous positive pressure versus the nasal intermittent positive pressure ventilation. |
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.
Ages Eligible for Study: | up to 1 Day |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Pernambuco | |
Maternal Infant Institute Prof Fernando Figueira | |
Recife, Pernambuco, Brazil, 50.070-550 |
Study Director: | Joao Guilherme B Alves, PhD | Instituto Materno Infantil Prof. Fernando Figueira |
Responsible Party: | Neonatal Unit of the Maternal-Infant Institute Prof. Fernando Figueira ( Jucille do Amaral Meneses ) |
Study ID Numbers: | IMIP123 |
Study First Received: | January 12, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821119 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
non invasive ventilation mechanical ventilation pulmonary morbidity preterm infant |
Respiratory distress syndrome nasal intermittent positive pressure nasal continuous positive pressure bronchopulmonary dysplasia |
Bronchopulmonary Dysplasia Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
Pathologic Processes Disease Respiratory Tract Diseases Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult |