Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants (NIV NAVA)

University of Oulu

Status: Completed

Conditions: Respiratory Distress Syndrome (RDS) of Neonate

Treatments: Device: Nasal continuous positive airway pressure; Device: NIV NAVA

Study type: Interventional

Funder types: Other

Identifiers

NCT01624012

EETTMK:23/2011

Details and patient eligibility

About

The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.

The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.

Enrollment: 40 patients

Sex: All

Ages: 1 to 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postconceptional age 28+0 - 36+6
• need of ncpap treatment and inspired oxygen for at least 60 minutes

Exclusion criteria

• severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
• any condition which prevents insertion of naso/orogastric tube

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

NIV NAVA

Active Comparator group

Description:

Noninvasive ventilation in this group is practiced with NIV NAVA

Treatment:

Device: NIV NAVA

ncpap

Active Comparator group

Description:

Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.

Treatment:

Device: Nasal continuous positive airway pressure