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

January 30, 2017 updated by: Dr Guillaume Emeriaud, St. Justine's Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • St. Justine's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 days to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NeuroBox to deliver the NeuroPAP
Device: NeuroBox to deliver the NeuroPAP

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time effectively spent with NeuroPAP mode activated during the NeuroPAP period
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
Percentage
up to 30 minutes after reinstitution of the conventional NIPPV
Number of interruption of NeuroPAP during the NeuroPAP period
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
Number of interruption per patients
up to 30 minutes after reinstitution of the conventional NIPPV
Change in respiratory rates between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV
Change in cardiac rates between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV
Change in blood pressure between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV
Change in SpO2 between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV
Change in TcPCO2 between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time spent in asynchrony between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of time
up to 30 minutes after reinstitution of the conventional NIPPV
Change in trigger delays (ms) between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV
Change in non assisted breaths (wasted efforts) between standard NIV andNeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
% of change
up to 30 minutes after reinstitution of the conventional NIPPV
Change in autotriggered breaths between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
Percentage
up to 30 minutes after reinstitution of the conventional NIPPV
Change in Mean Airway pressure (cmH2O) between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV
Change in End expiratory pressure (PEEP, cmH2O) between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV
Change in Mean Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV
Change in Peak Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV
Change in Tonic Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP
Time Frame: up to 30 minutes after reinstitution of the conventional NIPPV
up to 30 minutes after reinstitution of the conventional NIPPV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Justine's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maquet Cardiovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume Emeriaud, MD, PhD, St. Justine's Hospital
  • Principal Investigator: Gregory Lodygensky, MD, PhD, St. Justine's Hospital
  • Principal Investigator: Jennifer Beck, PhD, Li Ka Shing Knowledge Institute. St. Michael's Hospital
  • Principal Investigator: Christer Sinderby, PhD, Li Ka Shing Knowledge Institute. St. Michael's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUSJ-4083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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