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

January 14, 2015 updated by: Ufuk Cakir, Ankara University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bronchopulmonary dysplasia
Time Frame: 1 year
oxygen or pressure requirement on postmenstrual 36 weeks of gestational age
1 year
septal trauma rate
Time Frame: 1 year
any destruction on nose that require treatment after use of NIV
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Saadet ARSAN, Professor, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Map-NIV Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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