Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Device: binasal prongsDevice: nasal mask
- Registration Number
- NCT01989442
- Lead Sponsor
- Ankara University
- Brief Summary
The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.
The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.
- Detailed Description
Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit
- who are intubated in delivery room or neonatal intensive care unit before randomization
- with congenital anomaly
- patients who require NIV more than 3 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nasal prong binasal prongs patients who receive NIV by nasal prongs as interface after randomization Nasal Mask nasal mask patients who receive NIV by nasal mask interface after randomization
- Primary Outcome Measures
Name Time Method failure of NIV 1 year patients who require endotracheal intubation after NIV treatment
- Secondary Outcome Measures
Name Time Method ventilation duration 3 days both NIV and mechanical ventilation durations will be evaluated
Trial Locations
- Locations (1)
Ankara University
🇹🇷Ankara, Turkey