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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01624012

Acronym

NIV NAVA

Enrollment

Registered

2012-06-20

Start date

2011-08-31

Completion date

2016-05-31

Last updated

2016-05-12

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

Conditions

Respiratory Distress Syndrome (RDS) of Neonate

Keywords

NIV NAVA, non-invasive ventilation

Brief summary

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.

Interventions

DEVICENIV NAVA

Non invasive ventilation with neurally adjusted ventilatory assist

DEVICENasal continuous positive airway pressure

Noninvasive respiratory support with continuous positive airway pressure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 48 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
Duration of inspired oxygen supply	30minutes- 3weeks	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary

Measure	Time frame	Description
Duration of noninvasive ventilation	30 minutes - 3 weeks	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Fraction of inspired oxygen	0, 1, 3 and 6hours, after which every 6 hours	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Blood gas analyses	3 weeks	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Duration of parenteral nutrition	3 weeks	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Countries

Finland

Outcome results

None listed

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