VentilationNCT01156467
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
A study testing Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) in people with Ventilation, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA). The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to… Read more about this study
- Who is it for?
- Ages Up to 9 weeks
- Conditions the study is for
- Ventilation
- What is being tested?
- Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2010to Jun 2013
- 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 Up to 9 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes
Who cannot join
- severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
- condition which prevents the positioning of an oro-/nasogastric tube
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).
The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.
Read the detailed description
Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.
In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.
- Conditions
- Ventilation
- Being tested
- Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden), Control group, ventilation with i-Servo or Stephanie
- Keywords
- Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal
- Medical subject headings
- Respiratory Aspiration, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Device
Treatment with Edi-catheter
Control group, ventilation with i-Servo or StephanieDevice
Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done. Receives: Device: Control group, ventilation with i-Servo or Stephanie |
| NAVA | Active comparator | Infants randomised to this arm will receive and Edi-catheter as an oro-/nasogastric tube and the Edi-signal will be monitored and when possible NAVA-ventilation used. Receives: Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of mechanical ventilation
Measured: 1 hour - 6 weeks
Secondary outcomes (1)
Complications associated to mechanical ventilation
Measured: 1 hour - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies 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
- 60 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
- Investigators
- Timo Saarela, MD, PhD, Study director, Oulu University HospitalMerja Ålander, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156467
- Sponsor's protocol ID
- EETTMK:26/2010
- Status last verified
- Jun 2013
- First submitted
- 1 Jul 2010
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
- ClinicalTrials.gov ID
- NCT01156467
- Acronym / sponsor ID
- EETTMK:26/2010
- Conditions
- Ventilation
- Keywords
- Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Jul 2010 (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 find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).
The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.
Detailed description
Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.
In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Control group, ventilation with i-Servo or StephanieInfants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done. |
| NAVA | Active comparator | Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Infants randomised to this arm will receive and Edi-catheter as an oro-/nasogastric tube and the Edi-signal will be monitored and when possible NAVA-ventilation used. |
Who may qualify
- Ages
- Up to 9 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes
Key exclusion criteria (2 listed)
- severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
- condition which prevents the positioning of an oro-/nasogastric 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 |
|---|---|---|
| Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Treatment with Edi-catheter | Device | NAVA |
| Control group, ventilation with i-Servo or StephanieVentilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used. | Device | Control |
Primary outcome
The duration of mechanical ventilation
Time frame: 1 hour - 6 weeks
1 secondary outcome
Complications associated to mechanical ventilation
Time frame: 1 hour - 6 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 11 Jun 2013.
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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.
Timo Saarela, MD, PhD study director
Oulu University Hospital
Merja Ålander, MD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) in people with Ventilation, 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 1 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 11 Jun 2013. 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?
The duration of mechanical ventilation (time frame: 1 hour - 6 weeks). 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 11 Jun 2013.