Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants (NIV NAVA)
This study is currently recruiting participants.
Verified June 2012 by University of Oulu
Sponsor:
University of Oulu
Information provided by (Responsible Party):
Merja Ålander, University of Oulu
ClinicalTrials.gov Identifier:
NCT01624012
First received: June 4, 2012
Last updated: June 17, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Distress Syndrome (RDS) of Neonate |
Device: NIV NAVA Device: Nasal continuous positive airway pressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants |
Resource links provided by NLM:
Further study details as provided by University of Oulu:
Primary Outcome Measures:
- Duration of inspired oxygen supply [ Time Frame: 30minutes- 3weeks ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcome Measures:
- Duration of noninvasive ventilation [ Time Frame: 30 minutes - 3 weeks ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Fraction of inspired oxygen [ Time Frame: 0, 1, 3 and 6hours, after which every 6 hours ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Blood gas analyses [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
- Duration of parenteral nutrition [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: NIV NAVA
Noninvasive ventilation in this group is practiced with NIV NAVA
|
Device: NIV NAVA
Non invasive ventilation with neurally adjusted ventilatory assist
|
|
Active Comparator: ncpap
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
Noninvasive respiratory support with continuous positive airway pressure
|
Eligibility| Ages Eligible for Study: | up to 48 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624012
Contacts
| Contact: Merja Ålander, MD | +358-44-5825148 | merja.alander@oulu.fi |
| Contact: Timo Saarela, MD, PhD | +358-8-3155169 | timo.saarela@ppshp.fi |
Locations
| Finland | |
| Oulu University hospital | Recruiting |
| Oulu, Finland, 90230 | |
| Contact: Merja Ålander, MD merja.alander@oulu.fi | |
| Contact: Timo Saarela, MD, PhD timo.saarela@ppshp.fi | |
| Principal Investigator: Merja Ålander, MD | |
| Principal Investigator: Mari Mahlman, MD | |
| Sub-Investigator: Ulla Jounio, MD | |
| Sub-Investigator: Eija Anttila, MD | |
| Sub-Investigator: Outi Peltoniemi, MD, PhD | |
| Principal Investigator: Timo Saarela, MD, PhD | |
| Principal Investigator: Mikko Hallman, Prof | |
Sponsors and Collaborators
University of Oulu
More Information
No publications provided
| Responsible Party: | Merja Ålander, Principal investigator, University of Oulu |
| ClinicalTrials.gov Identifier: | NCT01624012 History of Changes |
| Other Study ID Numbers: | EETTMK:23/2011 |
| Study First Received: | June 4, 2012 |
| Last Updated: | June 17, 2012 |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
Keywords provided by University of Oulu:
|
NIV NAVA non-invasive ventilation |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 19, 2013