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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Mask

patients who receive NIV by nasal mask interface after randomization

Group Type EXPERIMENTAL

nasal mask

Intervention Type DEVICE

patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

nasal prong

patients who receive NIV by nasal prongs as interface after randomization

Group Type ACTIVE_COMPARATOR

binasal prongs

Intervention Type DEVICE

patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support

Interventions

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binasal prongs

patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support

Intervention Type DEVICE

nasal mask

patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

Intervention Type DEVICE

Other Intervention Names

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viasys healthcare infant flow system- binasal prongs viasys healthcare infant flow system-nasal mask

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No