Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Device: binasal prongs
* Device: nasal mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit Exclusion Criteria: who are intubated in delivery room or neonatal intensive care unit before randomization with congenital anomaly patients who require NIV more than 3 days

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal Mask<br>patients who receive NIV by nasal mask interface after randomization | Device: nasal mask<br>* patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support<br>* Other names: viasys healthcare infant flow system-nasal mask;|
| Active Comparator: nasal prong<br>patients who receive NIV by nasal prongs as interface after randomization | Device: binasal prongs<br>* patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support<br>* Other names: viasys healthcare infant flow system- binasal prongs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure of NIV | patients who require endotracheal intubation after NIV treatment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation duration | both NIV and mechanical ventilation durations will be evaluated | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation