Respiratory Distress Syndrome (RDS) of NeonateNIV NAVANCT01624012
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
A study testing NIV NAVA and Nasal continuous positive airway pressure in people with Respiratory Distress Syndrome (RDS) of Neonate, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Respiratory Distress Syndrome (RDS) of Neonate
- What is being tested?
- NIV NAVA and Nasal continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2011to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- postconceptional age 28+0 - 36+6
- need of ncpap treatment and inspired oxygen for at least 60 minutes
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
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.
- Being tested
- NIV NAVA, Nasal continuous positive airway pressure
- Keywords
- NIV NAVA, non-invasive ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV NAVADevice
Non invasive ventilation with neurally adjusted ventilatory assist
Nasal continuous positive airway pressureDevice
Noninvasive respiratory support with continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| NIV NAVA | Active comparator | Noninvasive ventilation in this group is practiced with NIV NAVA Receives: 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. Receives: Device: Nasal continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of inspired oxygen supply
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 30minutes- 3weeks
Secondary outcomes (4)
Duration of noninvasive ventilation
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 30 minutes - 3 weeks
Fraction of inspired oxygen
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 0, 1, 3 and 6hours, after which every 6 hours
Blood gas analyses
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Measured: 3 weeks
Duration of parenteral nutrition
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (RDS) of NeonateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merja Ålander, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624012
- Sponsor's protocol ID
- EETTMK:23/2011
- Acronym
- NIV NAVA
- Status last verified
- May 2016
- First submitted
- 4 Jun 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
- ClinicalTrials.gov ID
- NCT01624012
- Acronym / sponsor ID
- NIV NAVA / EETTMK:23/2011
- Keywords
- NIV NAVA, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV NAVA | Active comparator | Device: NIV NAVANoninvasive ventilation in this group is practiced with NIV NAVA |
| ncpap | Active comparator | Device: Nasal continuous positive airway pressurePatients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit. |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- postconceptional age 28+0 - 36+6
- need of ncpap treatment and inspired oxygen for at least 60 minutes
Key exclusion criteria (2 listed)
- severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
- any condition which prevents insertion of naso/orogastric tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV NAVANon invasive ventilation with neurally adjusted ventilatory assist | Device | NIV NAVA |
| Nasal continuous positive airway pressureNoninvasive respiratory support with continuous positive airway pressure | Device | ncpap |
Primary outcome
Duration of inspired oxygen supply
Time frame: 30minutes- 3weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
4 secondary outcomes
Duration of noninvasive ventilation
Time frame: 30 minutes - 3 weeks
Fraction of inspired oxygen
Time frame: 0, 1, 3 and 6hours, after which every 6 hours
Blood gas analyses
Time frame: 3 weeks
Duration of parenteral nutrition
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV NAVA and Nasal continuous positive airway pressure in people with Respiratory Distress Syndrome (RDS) of Neonate, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of inspired oxygen supply (time frame: 30minutes- 3weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.