NCT01989442

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DEVICE	binasal prongs	patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support
DEVICE	nasal mask	patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-06-01
• Completion: 2015-01-01
• First posted: 2013-11-21
• Last updated: 2015-01-15

Locations

1 site across 1 country: Turkey (Türkiye)