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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Mask | Experimental | patients who receive NIV by nasal mask interface after randomization |
|
| nasal prong | Active Comparator | patients who receive NIV by nasal prongs as interface after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| binasal prongs | Device | patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support |
|
| Measure | Description | Time Frame |
|---|---|---|
| failure of NIV | patients who require endotracheal intubation after NIV treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| ventilation duration | both NIV and mechanical ventilation durations will be evaluated | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| bronchopulmonary dysplasia | oxygen or pressure requirement on postmenstrual 36 weeks of gestational age | 1 year |
| septal trauma rate | any destruction on nose that require treatment after use of NIV |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ankara University | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Saadet ARSAN, Professor | Ankara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University | Recruiting | Ankara | Ankara | 06300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23897911 | Background | McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29. | |
| 23090339 | Background | Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| nasal mask | Device | patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support |
|
|
| 1 year |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |