Infant, PrematurePhase 1/2NCT00536445
Use of NAVA in Intubated Preterm
A Phase 1/2 study testing NAVA in people with Infant, Premature and Respiration, Artificial, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Infant, Premature, Respiration, Artificial
- What is being tested?
- NAVA
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 1/2
- 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 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm newborn (>1 day postnatal age, gestational age >23 weeks, birth weight <1250g), intubated and mechanically ventilated, and breathing spontaneously, as defined by the ability to trigger the ventilator. The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support < 22 cm H2O, PEEP 4-6 cm H2O Fi02<.30
Who cannot join
- Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability, cyanotic congenital cardiovascular disease, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory or jet ventilation, contraindication to changing NG tube, or if infant is deemed "too unstable" by the clinical team. The use of narcotics is an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Neurally Adjusted Ventilatory Assist (NAVA) in an Intubated Premature Infant: A Case Control Study on the Servoi Ventilator
The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in neonates by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the Servoi for 12 hours.
- Conditions
- Infant, Premature, Respiration, Artificial
- Being tested
- NAVA
- Keywords
- NAVA, Preterm, Case study
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
Also called Servoi (Maquet Critical Care AB)
Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
What is being measured
The primary outcome is the main question the study is designed to answer.
• Patient-ventilator synchrony (trigger delays, cycling-off delays) • Phasic electrical activity of the diaphragm EAdi • Tonic EAdi • tidal volume, airway pressure, respiratory rate • Oxygen saturation, transcutaneous CO2, FIO2
Measured: end of the 12 hour trial
Secondary outcomes (1)
• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments
Measured: end of the 12 hour trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Another institution performed the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Michael Dunn, MD, Principal investigator, Sunnybrook Health Sciences CentreJennifer Beck, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536445
- Sponsor's protocol ID
- 124-2007
- Status last verified
- May 2016
- First submitted
- 25 Sep 2007
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck J, Campoccia F, Allo JC, Brander L, Brunet F, Slutsky AS, Sinderby C. Improved synchrony and respiratory unloading by neurally adjusted ventilatory assist (NAVA) in lung-injured rabbits. Pediatr Res. 2007 Mar;61(3):289-94. doi: 10.1203/01.pdr.0000257324.22406.93.
PubMed 17314685
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Neurally Adjusted Ventilatory Assist (NAVA) in an Intubated Premature Infant: A Case Control Study on the Servoi Ventilator
- ClinicalTrials.gov ID
- NCT00536445
- Acronym / sponsor ID
- 124-2007
- Conditions
- Infant, Premature, Respiration, Artificial
- Keywords
- NAVA, Preterm, Case study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Another institution performed the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 27 Sep 2007 (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 present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in neonates by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the Servoi for 12 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm newborn (>1 day postnatal age, gestational age >23 weeks, birth weight <1250g), intubated and mechanically ventilated, and breathing spontaneously, as defined by the ability to trigger the ventilator. The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support < 22 cm H2O, PEEP 4-6 cm H2O Fi02<.30
Key exclusion criteria (1 listed)
- Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability, cyanotic congenital cardiovascular disease, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory or jet ventilation, contraindication to changing NG tube, or if infant is deemed "too unstable" by the clinical team. The use of narcotics is an exclusion criteria.
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 |
|---|---|---|
| NAVAAlso: Servoi (Maquet Critical Care AB)Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity) | Device | – |
Primary outcome
• Patient-ventilator synchrony (trigger delays, cycling-off delays) • Phasic electrical activity of the diaphragm EAdi • Tonic EAdi • tidal volume, airway pressure, respiratory rate • Oxygen saturation, transcutaneous CO2, FIO2
Time frame: end of the 12 hour trial
1 secondary outcome
• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments
Time frame: end of the 12 hour trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 17314685Beck J, Campoccia F, Allo JC, Brander L, Brunet F, Slutsky AS, Sinderby C. Improved synchrony and respiratory unloading by neurally adjusted ventilatory assist (NAVA) in lung-injured rabbits. Pediatr Res. 2007 Mar;61(3):289-94. doi: 10.1203/01.pdr.0000257324.22406.93.
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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.
Michael Dunn, MD principal investigator
Sunnybrook Health Sciences Centre
Jennifer Beck, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NAVA in people with Infant, Premature and Respiration, Artificial, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 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: withdrawn, as of the sponsor's last update on 1 Jun 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
• Patient-ventilator synchrony (trigger delays, cycling-off delays) • Phasic electrical activity of the diaphragm EAdi • Tonic EAdi • tidal volume, airway pressure, respiratory rate • Oxygen saturation, transcutaneous CO2, FIO2 (time frame: end of the 12 hour trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536445, which also lists 1 linked publication.
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 1 Jun 2016.