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

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Bronchopulmonary dysplasia
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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