Respiratory Distress Syndrome, NewbornNCT05427929
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
A study testing NVR 4mm Edi catheter in people with Respiratory Distress Syndrome, Newborn and Infant, Premature, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Infant, Premature
- What is being tested?
- NVR 4mm Edi catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates with current weight <1000g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment.
Who cannot join
- Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective
- Known congenital or chromosomal anomalies
- Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension
- Parental consent not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries.
In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm).
Read more
While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight < 1000 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long).
In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.
Read the detailed description
This is an unblinded pilot study to evaluate the performance of the new 4 mm IED. The procedures required for this evaluation include placement of the new NVR 4 mm Edi catheter, and ventilation in the NAVA mode. All these procedures are considered to have no significant additional risk. Supervision by a physician or respiratory therapist with expertise in Edi catheter and NAVA will be present, in line with the current clinical practice in the Mount Sinai NICU.
- Being tested
- NVR 4mm Edi catheter
- Keywords
- Preterm Neonates, NAVA Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVR 4mm Edi catheterDevice
Receive NAVA ventilation using the newly designed NVR 4 mm Edi catheter
| Study group | Role | What they receive |
|---|---|---|
| NVR 4mm Edi Catheter | Experimental | Not described Receives: Device: NVR 4mm Edi catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter
Categorical (yes/no) - Feasibility will be defined as 4mm catheters picking up EDI signals and allowing initiation of NAVA ventilation as per the standard clinical practice. Cases where clinical team is unable to initiate NAVA, necessitating change back to 6 mm catheters will be termed non-feasible.
Measured: During study catheter change (total study length = 2 hours during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start12 Jan 2023
- Primary completion10 Jul 2024
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Amish Jain, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427929
- Sponsor's protocol ID
- 21-0224-A
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
- ClinicalTrials.gov ID
- NCT05427929
- Acronym / sponsor ID
- 21-0224-A
- Keywords
- Preterm Neonates, NAVA Ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- 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.
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries.
In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm).
While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight < 1000 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long).
In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.
Detailed description
This is an unblinded pilot study to evaluate the performance of the new 4 mm IED. The procedures required for this evaluation include placement of the new NVR 4 mm Edi catheter, and ventilation in the NAVA mode. All these procedures are considered to have no significant additional risk. Supervision by a physician or respiratory therapist with expertise in Edi catheter and NAVA will be present, in line with the current clinical practice in the Mount Sinai NICU.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVR 4mm Edi Catheter | Experimental | Device: NVR 4mm Edi catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates with current weight <1000g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment.
Key exclusion criteria (4 listed)
- Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective
- Known congenital or chromosomal anomalies
- Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension
- Parental consent not available
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 |
|---|---|---|
| NVR 4mm Edi catheterReceive NAVA ventilation using the newly designed NVR 4 mm Edi catheter | Device | NVR 4mm Edi Catheter |
Primary outcome
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter
Time frame: During study catheter change (total study length = 2 hours during procedure)
Categorical (yes/no) - Feasibility will be defined as 4mm catheters picking up EDI signals and allowing initiation of NAVA ventilation as per the standard clinical practice. Cases where clinical team is unable to initiate NAVA, necessitating change back to 6 mm catheters will be termed non-feasible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
Amish Jain principal investigator
MOUNT SINAI 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 NVR 4mm Edi catheter in people with Respiratory Distress Syndrome, Newborn and Infant, Premature, run by Mount Sinai Hospital, Canada 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 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter (time frame: During study catheter change (total study length = 2 hours during procedure)). 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 16 Oct 2026.