Respiratory Distress SyndromeNCT01588080
Comparison Between Infant Flow SiPAP and Noninvasive NAVA in the Neonatal Intensive Care Unit
A study testing Neurally Adjusted Ventilatory Assist (NAVA) in people with Respiratory Distress Syndrome, run by Fraser Health at 2 sites in Canada.
Trial summary
When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Neurally Adjusted Ventilatory Assist (NAVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2012to Nov 2014
- 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 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation
- Diagnosis of RDS in the first 24 hours of life requiring respiratory support
- Parental consent obtained
Who cannot join
- Infants with a major congenital anomaly
- Infants with pulmonary hypoplasia
- Infants known or suspected to have a neuromuscular disorder
- Infants less than 28+0 weeks GA
- Intubated infants that are likely to require continued mechanical ventilation
- Infants requiring vigorous resuscitation at birth, including chest compressions +/- cardiac medications
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
Surrey Memorial Hospital
Surrey, British Columbia, V3V1Z2
About this study
Official title: A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA
When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. The breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. A new device called neurally adjusted ventilatory assist or NAVA is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. When using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. The objective of this pilot study is to compare this new breathing device called NAVA, to the equipment that is currently being used, called SiPAP, to support premature newborn's breathing after birth without a breathing tube. The investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid intubation.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Neurally Adjusted Ventilatory Assist (NAVA), SiPAP - placebo
- 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.
Neurally Adjusted Ventilatory Assist (NAVA)Device
Neurally adjusted ventilatory assist (NAVA), an adjunct that can only be used with the Servo-i ventilator, allows the patient to synchronize spontaneous respiratory effort with mechanical ventilation. NAVA uses the electromyographic signal of the diaphragm (Edi) to transmit this electrical activity back to the ventilator. The NAVA catheter is a functional gastric tube that has electrodes embedded within it and positioned at the level of diaphragm using an electrocardiogram signal. These electrodes continuously (every 5ms) detect the amplitude, duration, and frequency of the Edi and provide pressure support in proportion to this electrical activity. Proportionality is controlled by a NAVA factor (cmH20/microvolt) and is adjusted by the user.
SiPAP - placeboDevice
The Infant Flow® SiPAP provides noninvasive support to neonates. CPAP and Biphasic modes are provided by the Infant Flow® SiPAP. CPAP is an elevated pressure (above atmospheric) and is used to increase a premature babies functional residual capacity (FRC). CPAP is a modality used for babies with both central apneas and mild/moderate increase work of breathing. CPAP increases the FRC and ultimately recruits collapsed alveoli and improves gas exchange in the lungs. BiPhasic, on the other hand, is a modality used for babies that require more respiratory support than CPAP can provide. In BiPhasic mode, respiratory rate (RR), inspiratory time (Ti), and peak inspiratory pressures (PIP) are set and not synchronized with the patients breathing efforts.
| Study group | Role | What they receive |
|---|---|---|
| SiPAP | Placebo comparator | Not described Receives: Device: SiPAP - placebo |
| Neurally Adjusted Ventilatory Assist | Experimental | Not described Receives: Device: Neurally Adjusted Ventilatory Assist (NAVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)
Measured: one year
Secondary outcomes (10)
Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation
Measured: one year
All cause mortality during the hospitalization
Measured: one year
Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA
Measured: one year
Number of doses of surfactant
Measured: one year
Incidence of pneumothorax
Measured: one year
Total duration of oxygen requirement
Measured: one year
Incidence of nasal deformities, specifically nasal erosions
Measured: one year
Time to reach full volume feeds (at least 120 ml/kg/day)
Measured: one year
Time to regain birth weight
Measured: one year
Total length of hospital stay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravinder Kajla, Fraser Health
- Investigators
- Ravinder Kajla, Principal investigator, Fraser HealthRebecca Sherlock, MD, Study chair, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588080
- Sponsor's protocol ID
- NAVA
- Status last verified
- May 2015
- First submitted
- 26 Apr 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA
- ClinicalTrials.gov ID
- NCT01588080
- Acronym / sponsor ID
- NAVA
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Apr 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.
When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. The breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. A new device called neurally adjusted ventilatory assist or NAVA is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. When using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. The objective of this pilot study is to compare this new breathing device called NAVA, to the equipment that is currently being used, called SiPAP, to support premature newborn's breathing after birth without a breathing tube. The investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SiPAP | Placebo comparator | Device: SiPAP - placebo |
| Neurally Adjusted Ventilatory Assist | Experimental | Device: Neurally Adjusted Ventilatory Assist (NAVA) |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation
- Diagnosis of RDS in the first 24 hours of life requiring respiratory support
- Parental consent obtained
Key exclusion criteria (6 listed)
- Infants with a major congenital anomaly
- Infants with pulmonary hypoplasia
- Infants known or suspected to have a neuromuscular disorder
- Infants less than 28+0 weeks GA
- Intubated infants that are likely to require continued mechanical ventilation
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 (NAVA)Neurally adjusted ventilatory assist (NAVA), an adjunct that can only be used with the Servo-i ventilator, allows the patient to synchronize spontaneous respiratory effort with mechanical ventilation. NAVA uses the electromyographic signal of the diaphragm (Edi) to transmit this electrical activity back to the ventilator. The NAVA catheter is a functional gastric tube that has electrodes embedded within it and positioned at the level of diaphragm using an electrocardiogram signal. These electrodes continuously (every 5ms) detect the amplitude, duration, and frequency of the Edi and provide pressure support in proportion to this electrical activity. Proportionality is controlled by a NAVA factor (cmH20/microvolt) and is adjusted by the user. | Device | Neurally Adjusted Ventilatory Assist |
| SiPAP - placeboThe Infant Flow® SiPAP provides noninvasive support to neonates. CPAP and Biphasic modes are provided by the Infant Flow® SiPAP. CPAP is an elevated pressure (above atmospheric) and is used to increase a premature babies functional residual capacity (FRC). CPAP is a modality used for babies with both central apneas and mild/moderate increase work of breathing. CPAP increases the FRC and ultimately recruits collapsed alveoli and improves gas exchange in the lungs. BiPhasic, on the other hand, is a modality used for babies that require more respiratory support than CPAP can provide. In BiPhasic mode, respiratory rate (RR), inspiratory time (Ti), and peak inspiratory pressures (PIP) are set and not synchronized with the patients breathing efforts. | Device | SiPAP |
Primary outcome
total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)
Time frame: one year
10 secondary outcomes
Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation
Time frame: one year
All cause mortality during the hospitalization
Time frame: one year
Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA
Time frame: one year
Number of doses of surfactant
Time frame: one year
Incidence of pneumothorax
Time frame: one year
Total duration of oxygen requirement
Time frame: one year
Incidence of nasal deformities, specifically nasal erosions
Time frame: one year
Time to reach full volume feeds (at least 120 ml/kg/day)
Time frame: one year
Time to regain birth weight
Time frame: one year
Total length of hospital stay
Time frame: one year
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 27 May 2015.
Related trials for Respiratory Distress Syndrome
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Active, not recruitingObservational study
Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding
ARDS, ARDS Disease Progression
RecruitingObservational study
Respiratory Distress and Elective Cesarean Section at Term
Respiratory Distress Syndrome
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.
Ravinder Kajla principal investigator
Fraser Health
Rebecca Sherlock, MD study chair
Fraser Health
2 sites 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 (NAVA) in people with Respiratory Distress Syndrome, run by Fraser Health at 2 sites 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 3 inclusion and 6 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS) (time frame: one year). 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 27 May 2015.