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Respiratory FailureNeuroPAPNCT02480205

A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns

A study testing NeuroBox to deliver the NeuroPAP in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are… Read more about this study

Who is it for?
Ages 3 days to 1 month
Conditions the study is for
Respiratory Failure
What is being tested?
NeuroBox to deliver the NeuroPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Aug 2015to 30 Jan 2017
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 3 days to 1 month
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Preterm infants, >26 0/7 and < 34 weeks GA, at least 3 days old and younger than 1 month,
  • on NIPPV with settings in the range : Maximal inspiratory pressure (total, including PEEP) < 20 cmH2O, and PEEP : 5-7 cmH2O,
  • with FiO2 <40%, and stable.

Who cannot join

  • Suspected or proven pneumothorax
  • Patient on high-flow nasal cannula or nasal continuous positive airway pressure (nCPAP)
  • Infants with severe recurring apnea
  • Recent worsening of respiratory status with increase work of breathing, recent increase in FiO2, or linked with a suspected sepsis
  • Contraindications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions)
  • Hemodynamic instability requiring inotropes.
Show all 9Show fewer
  • Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 45%, or PaCO2 > 65 mmHg on blood gas in the last hour.
  • Patient for whom a limitation of life support treatments is discussed or decided.
  • Refusal by the treating physician.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Justine's Hospital

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed. Considering that preterm infants are more likely to develop atelectasis, an active and ongoing management of the PEEP is very important to prevent de-recruitment.

A new respiratory support system (NeuroPAP) was developed to address these issues (synchronization problems and control the PEEP). It uses the electrical activity of the diaphragm (EDI) to control the ventilator assist continuously, both during inspiration (principle of NAVA mode) and also during expiration (based on tonic Edi level).

Read the detailed description

The mode NeuroPAP will work with the continuous Edi-level and deliver pressures according to the Edi-signal x set NeuroPAP-level, over the whole breath (inspiration and expiration). The NeuroPAP will work between two pressure levels set by the user and named higher Pressure limit (Plimit) and minimum Pressure (Pmin).

A safety upper pressure limit (UPL) will also be set. A backup ventilation will be possible.

A specific gastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion, by the same oral or nasal route as the tube previously in place. Patients will then be ventilated in the 5 aforementioned conditions:

  • On conventional NIPPV device on clinical settings for a 30 minute period. The investigators will note the mean airway pressure being delivered with the clinical settings and the resulting peak Edi, as well as neural respiratory rate, tonic Edi, Fraction of inspired oxygen (FiO2), and Oxygen saturation by pulse oximetry (SpO2).
  • With NeuroPAP without modification of Pmin (=peep). The exchange of the nasal interface may be necessary, depending on the original interface. FiO2 will initially be the same as previously set in conventional NIPPV. The Pmin will initially be set at the level of PEEP used during conventional NIPPV. A titration maneuver will be conducted to identify the optimal NeuroPAP level. The infant will be ventilated for one hour. Clinical adjustments in pressures and FiO2 are permitted. Safety termination will be established.
  • NeuroPAP with adjusted Pmin: the Pmin in NeuroPAP will be reduced by 2 cm H2O, with the same NeuroPAP level. The patients will be ventilated for one hour.
  • CPAP delivery with NeuroPAP device: the device will be switched to CPAP mode, for a 15 minute period
  • A second 30 minutes period of the conventional NIPPV will be conducted.
Being tested
NeuroBox to deliver the NeuroPAP
Keywords
CPAP, NIV, NIPPV, Edi
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuroBox to deliver the NeuroPAPDevice

    The patients will be studied during the following conditions:

    • On conventional NIPPV device with the clinically prescribed settings (30 min)
    • With NeuroPAP and no change of Pmin (=peep) (60 min)
    • With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min)
    • During CPAP delivered with NeuroPAP device (15 min)
    • Again with original NIPPV device and settings for 30 minutes
Study groups in NCT02480205
Study groupRoleWhat they receive
NeuroBox to deliver the NeuroPAPExperimentalNot described
Receives: Device: NeuroBox to deliver the NeuroPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time effectively spent with NeuroPAP mode activated during the NeuroPAP period

    Percentage

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  2. Number of interruption of NeuroPAP during the NeuroPAP period

    Number of interruption per patients

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  3. Change in respiratory rates between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  4. Change in cardiac rates between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  5. Change in blood pressure between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  6. Change in SpO2 between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  7. Change in TcPCO2 between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

Secondary outcomes (9)

  1. Time spent in asynchrony between standard NIV and NeuroPAP

    % of time

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  2. Change in trigger delays (ms) between standard NIV andNeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  3. Change in non assisted breaths (wasted efforts) between standard NIV andNeuroPAP

    % of change

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  4. Change in autotriggered breaths between standard NIV and NeuroPAP

    Percentage

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  5. Change in Mean Airway pressure (cmH2O) between standard NIV and NeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  6. Change in End expiratory pressure (PEEP, cmH2O) between standard NIV and NeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  7. Change in Mean Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  8. Change in Peak Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

  9. Change in Tonic Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP

    Measured: up to 30 minutes after reinstitution of the conventional NIPPV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion30 Jan 2017
  4. Study completion30 Jan 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480205
Sponsor's protocol ID
CHUSJ-4083
Acronym
NeuroPAP
Status last verified
Jan 2017
First submitted
26 May 2015
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Rochon ME, Lodygensky G, Tabone L, Essouri S, Morneau S, Sinderby C, Beck J, Emeriaud G. Continuous neurally adjusted ventilation: a feasibility study in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):640-645. doi: 10.1136/archdischild-2019-318660. Epub 2020 Apr 8.

    PubMed 32269148

Questions about this trial

What is this clinical trial studying?

A study testing NeuroBox to deliver the NeuroPAP in people with Respiratory Failure, run by St. Justine's Hospital 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 3 inclusion and 9 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 31 Jan 2017. 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?

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?

Time effectively spent with NeuroPAP mode activated during the NeuroPAP period (time frame: up to 30 minutes after reinstitution of the conventional NIPPV). The study lists 7 primary outcomes in all. 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 NCT02480205, 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 31 Jan 2017.

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