Brief Title
Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
Official Title
Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
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.
Study Type
Interventional
Primary Outcome
failure of NIV
Secondary Outcome
ventilation duration
Condition
Bronchopulmonary Dysplasia
Intervention
binasal prongs
Study Arms / Comparison Groups
Nasal Mask
Description: patients who receive NIV by nasal mask interface after randomization
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
November 2013
Completion Date
January 2015
Primary Completion Date
June 2014
Eligibility Criteria
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
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Saadet ARSAN, Professor, ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT01989442
Organization ID
Map-NIV Trial
Responsible Party
Principal Investigator
Study Sponsor
Ankara University
Study Sponsor
Saadet ARSAN, Professor, Principal Investigator, Ankara University
Verification Date
January 2015