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

Ankara University

Status: Unknown

Conditions: Bronchopulmonary Dysplasia

Treatments: Device: nasal mask; Device: binasal prongs

Study type: Interventional

Funder types: Other

Identifiers

NCT01989442

Map-NIV Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nasal Mask

Experimental group

Description:

patients who receive NIV by nasal mask interface after randomization

Treatment:

Device: nasal mask

nasal prong

Active Comparator group

Description:

patients who receive NIV by nasal prongs as interface after randomization

Treatment:

Device: binasal prongs