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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome (RDS) of Neonate
• Interventions: Device: NIV NAVA; Device: Nasal continuous positive airway pressure

• Registration Number: NCT01624012
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-17
• Study First Posted: 2012-06-20
• Primary Completion: 2015-08
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV NAVA	NIV NAVA	Noninvasive ventilation in this group is practiced with NIV NAVA
ncpap	Nasal continuous positive airway pressure	Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of parenteral nutrition	3 weeks	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 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

Trial Locations

Locations (1)

Oulu University hospital; 🇫🇮 Oulu, Finland