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

NCT01624012 | Completed

• 1 other identifier: EETTMK:23/2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome (RDS) of Neonate

Keywords

NIV NAVA; non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of inspired oxygen supply

  Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  30minutes- 3weeks

Secondary Outcomes (4)

• Duration of noninvasive ventilation

  30 minutes - 3 weeks

• Fraction of inspired oxygen

  0, 1, 3 and 6hours, after which every 6 hours

• Blood gas analyses

  3 weeks

• Duration of parenteral nutrition

  3 weeks

Study Arms (2)

NIV NAVA

ACTIVE COMPARATOR

Noninvasive ventilation in this group is practiced with NIV NAVA

Device: NIV NAVA

ncpap

ACTIVE COMPARATOR

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

Device: Nasal continuous positive airway pressure

Interventions

NIV NAVA DEVICE

Non invasive ventilation with neurally adjusted ventilatory assist

NIV NAVA

Nasal continuous positive airway pressure DEVICE

Noninvasive respiratory support with continuous positive airway pressure

ncpap

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University hospital

Oulu, 90230, Finland

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 20, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

FI (1)