Pediatric Respiratory DiseasesNeuroPap2NCT03650478

Assessment of NeuroBOX and NeuroPAP in Infants.

A study testing NeuroPAP ventilation (2h) and NeuroBox monitoring (23h) and NeuroPAP ventilation (4h) and NeuroBox monitoring (25h) in people with Pediatric Respiratory Diseases and Bronchiolitis, 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

Who is it for?: Ages 2 days to 4 months
Conditions the study is for: Pediatric Respiratory Diseases, Bronchiolitis, Infant Respiratory Distress Syndrome
What is being tested?: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h) and NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteCanada
Study dates: 1 Oct 2018to 31 Oct 2021
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 2 days to 4 months
All sexes
No healthy volunteers
Child

Who may be able to join

For premature infants group:
Preterm infants born at a gestational age (GA) between 25 weeks (+0/7 days) and 34 weeks inclusively
With post-birth age : > 2 days (for birth GA >28 weeks) or > 6 days (GA <28weeks) and < 4 months
on non-invasive support, including CPAP, NIPPV, or NAVA, with settings in the following range : Maximal inspiratory pressure (total, including PEEP) ≤ 20 cmH2O, and PEEP between 4 and 9 cmH2O, and FiO2 < 50%
For bronchiolitis group:
Infants with a weight < 5kg and a clinical diagnosis of bronchiolitis.

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on non-invasive support, including CPAP, NIPPV, or NAVA with settings in the range: Delivered inspiratory pressure (total, including PEEP) ≤ 20 cmH2O and PEEP: 5-9 cmH2O, and FiO2 <60 %
With persisting respiratory failure: presence of at least one of the following criteria:
Respiratory rate > 50 /min
Symptoms of respiratory distress: mWCAS > 3
FiO2 > 30% -
Inspiratory Edi consistently > 15 µV
Exclusion Criteria: for both premature infants and bronchiolitis groups
Suspected or proven pneumothorax;
Patient on high-flow nasal cannula or on NAVA;
Contra-indications 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 > 50% to achieve a SpO2>90%, or PaCO2 > 75 mmHg on the last blood gas;
Patient for whom a limitation of life support treatments is discussed or decided;
Refusal by the treating physician;
Refusal by the parents or legal guardians.

Who cannot join

None listed.

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

Official title: Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.

Non-invasive ventilation (NIV, delivered via a mask or cannulas) permits to reduce the need for tracheal intubation in infants who needs a ventilatory support. NIV can be delivered with nasal CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). The synchronization of the respiratory support according to the patient's demand is very difficult to obtain in infants with the conventional ventilatory modes. In all these ventilatory modes, the end-expiratory pressure (PEEP) is fixed and set by the clinician. However, since infants are prone to alveolar collapse and must compensate for a non-compliant chest wall, an active and ongoing management of PEEP is very important to prevent the lung de-recruitment.

A new respiratory support system (NeuroPAP) has been developed to address these issues of synchronization and control of PEEP. This new system uses diaphragmatic tonic activity (Edi) that reflects the patient's efforts to increase lung recruitment and therefore it continuously controls the delivery of assist continuously both during inspiration (like NAVA) and during expiration, allowing a unique neural control of PEEP.

A new device, the NeuroBOX, permits to deliver NIV with NeuroPAP, CPAP, or NIPPV, and also to serve as a cardio-respiratory monitor, tracking and displaying cardiac and respiratory signals, trends, and cardio-vascular events.

The two main objectives of this study are: 1- To evaluate the clinical impact of NeuroPAP in infants with high tonic Edi; 2- To characterize the cardio-respiratory pattern and its relationship with cerebral perfusion of infants with noninvasive support, using the monitoring capacity of the NeuroBOX.

The investigators expect that NeuroPAP will permit to improve the efficiency of NIV in infants, through the better synchronization and the personalization of the expiratory pressure level in response to the patient needs.

This study will be conducted in two subgroups of patients at high risk of elevated tonic Edi and of cardio-respiratory events: a subgroup of premature infants and a subgroup of infants with bronchiolitis.

Conditions: Pediatric Respiratory Diseases, Bronchiolitis, Infant Respiratory Distress Syndrome
Being tested: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h), NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
Keywords: Intensive Care, mechanical ventilation, noninvasive ventilation
Medical subject headings: Bronchiolitis, Pulmonary Atelectasis

What participants receive

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

NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)Device
Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted
NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)Device
Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted

Study groups in NCT03650478
Study group	Role	What they receive
Premature infants group	Experimental	NeuroPAP ventilation (2h) and NeuroBox monitoring (23h) Receives: Device: NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
Bronchiolitis group	Experimental	NeuroPAP ventilation (4h) and NeuroBox monitoring (25h) Receives: Device: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)

What is being measured

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

Changes in indices of respiratory unloading
The inspiratory and tonic Edi will be extracted from the NeuroBOX during each phase. The mWCAS, a clinical scale of work of breathing, will be blindly collected during each ventilatory condition in the bronchiolitis patients.
Measured: Last 5-minute period of each condition phase
Incidence of cardio-respiratory events
the number of apneas >20s, with and without desaturations and with/without bradycardia, and the number of bradycardia will be extracted from the NeuroBOX. This is a descriptive analysis, not a comparative analysis.
Measured: over 25 hours (Entire recordings)

Secondary outcomes (4)

Change in End expiratory lung volume (EELV) level
change in EELV will be assessed using the 3D video-derived volumetry, comparing the mean EELV level in the 5 minutes before and after the change of ventilatory mode (from conventional NIPPV to NeuroPAP and the reverse).
Measured: 5-minute period before and after the change of ventilatory mode
Change in Indices of cerebral oxygenation and perfusion
FDNIRS-DCS technology will be used to measure the indices of cerebral oxygen metabolism, blood flow and tissue hemoglobin saturation
Measured: Last 5-minute period of each condition phase
Change in comfort level in preterm infants
assessed by the bedside nurse in charge using the Pain/Agitation component of the validated scale N-PASS (neonatal pain, agitation, and sedation scale). The Pain/Agitation component varies from 0 to 10, and a lower score reflects a better comfort.
Measured: Last 5-minute period of each condition phase
Change in comfort level in infants with bronchiolitis.
assessed by the bedside nurse in charge using the validated scale FLACC (Face, Legs, Activity, Cry, Consolability scale). The FLACC score varies from 0 to 10 and a lower score reflects a better comfort.
Measured: Last 5-minute period of each condition phase

Timeline

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

1 Oct 201831 Oct 2021

First posted28 Aug 2018
Study start1 Oct 2018
Primary completion31 Oct 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pediatric Respiratory DiseasesStudies 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: Non-randomised
Intervention model: Crossover
Model description: Prospective single center crossover study with two different arms, one conducted in the Neonatal Intensive Care Unit and the other in the Pediatric Intensive Care Unit.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03650478
Sponsor's protocol ID: CHUSJ-1841
Acronym: NeuroPap2
Status last verified: Apr 2023
First submitted: 22 Aug 2018
Last updated: 18 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.
ClinicalTrials.gov ID: NCT03650478
Acronym / sponsor ID: NeuroPap2 / CHUSJ-1841
Conditions: Pediatric Respiratory Diseases, Bronchiolitis, Infant Respiratory Distress Syndrome
Keywords: Intensive Care, mechanical ventilation, noninvasive ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: St. Justine's HospitalUniversity, hospital or other
Collaborators: Maquet Critical Care AB
Study start: 1 Oct 2018 (actual)
Primary completion: 31 Oct 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 28 Aug 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Prospective single center crossover study with two different arms, one conducted in the Neonatal Intensive Care Unit and the other in the Pediatric Intensive Care Unit.

Arm	Type	Receives
Premature infants group	Experimental	Device: NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)
Bronchiolitis group	Experimental	Device: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)

Who may qualify

Ages: 2 days to 4 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (21 listed)

Preterm infants born at a gestational age (GA) between 25 weeks (+0/7 days) and 34 weeks inclusively
With post-birth age : > 2 days (for birth GA >28 weeks) or > 6 days (GA <28weeks) and < 4 months
on non-invasive support, including CPAP, NIPPV, or NAVA, with settings in the following range : Maximal inspiratory pressure (total, including PEEP) ≤ 20 cmH2O, and PEEP between 4 and 9 cmH2O, and FiO2 < 50%
Infants with a weight < 5kg and a clinical diagnosis of bronchiolitis.
on non-invasive support, including CPAP, NIPPV, or NAVA with settings in the range: Delivered inspiratory pressure (total, including PEEP) ≤ 20 cmH2O and PEEP: 5-9 cmH2O, and FiO2 <60 %

Key exclusion criteria (0 listed)

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
NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted	Device	Bronchiolitis group
NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted	Device	Premature infants group

Primary outcome

Changes in indices of respiratory unloading
Time frame: Last 5-minute period of each condition phase
The inspiratory and tonic Edi will be extracted from the NeuroBOX during each phase. The mWCAS, a clinical scale of work of breathing, will be blindly collected during each ventilatory condition in the bronchiolitis patients.
Incidence of cardio-respiratory events
Time frame: over 25 hours (Entire recordings)
the number of apneas >20s, with and without desaturations and with/without bradycardia, and the number of bradycardia will be extracted from the NeuroBOX. This is a descriptive analysis, not a comparative analysis.

4 secondary outcomes

Change in End expiratory lung volume (EELV) level
Time frame: 5-minute period before and after the change of ventilatory mode
Change in Indices of cerebral oxygenation and perfusion
Time frame: Last 5-minute period of each condition phase
Change in comfort level in preterm infants
Time frame: Last 5-minute period of each condition phase
Change in comfort level in infants with bronchiolitis.
Time frame: Last 5-minute period of each condition phase

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 18 Apr 2023.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
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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.

Guillaume Emeriaud, MD PhD principal investigator

CHU Sainte Justine, Université de Montréal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 0 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 18 Apr 2023. 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?

Changes in indices of respiratory unloading (time frame: Last 5-minute period of each condition phase). The study lists 2 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 NCT03650478.

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 18 Apr 2023.