N/A
N=200
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
Prematurity · Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00821119 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Need for Endotracheal Ventilation in the First 72 hs of Life — 34; 25 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nasal intermittent positive pressure ventilation (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Endotracheal Ventilation in the First 72 hs of Life |
34; 25 | <0.05 sig |
| PRIMARY Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) |
34; 25 | 0.05 |
| SECONDARY Bronchopulmonary Dysplasia |
20; 22 | < 0.05 sig |
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)
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
Data sourced from ClinicalTrials.gov (NCT00821119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.