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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01989442

Acronym

NIV

Enrollment

100

Registered

2013-11-21

Start date

2013-11-30

Completion date

2015-01-31

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation

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.

Interventions

DEVICEbinasal prongs

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

DEVICEnasal mask

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

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

Design outcomes

Primary

Measure	Time frame	Description
failure of NIV	1 year	patients who require endotracheal intubation after NIV treatment

Secondary

Measure	Time frame	Description
ventilation duration	3 days	both NIV and mechanical ventilation durations will be evaluated

Other

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

Countries

Turkey (Türkiye)

Contacts

Primary ContactAnkara University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026