BronchiolitisNCT04408534
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
A study testing mode of noninvasive ventilation in people with Bronchiolitis, run by University Hospital, Grenoble.
Trial summary
This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea Read more about this study
- Who is it for?
- Ages 3 days to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- mode of noninvasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Mar 2022
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born at gestational age > 36 weeks gestation
- Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
- Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia < 80 / min, 2/Associated with desaturation < 85% or 3/Duration more than 10 seconds
- Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)
Who cannot join
- With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
- Ventilated in NIV for more than 48 hours before inclusion
- Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
- Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
- Patient not affiliated to health care insurance
About this study
This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea
Read the detailed description
This study is a cross over randomized study which aims to compare the effect of 2 modes of noninvasive ventilation on the occurence of central apnea, as measured by electrical activity of the diaphragm
- Conditions
- Bronchiolitis
- Being tested
- mode of noninvasive ventilation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mode of noninvasive ventilationOther
administration of during 3 hours each 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Active comparator | Patients receive continuous positive airway pressure as a mode of noninvasive ventilation Receives: Other: mode of noninvasive ventilation |
| bilevel positive airway pressure | Experimental | Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation Receives: Other: mode of noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea
Number of apnea
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408534
- Sponsor's protocol ID
- 2020-A01183-36
- Status last verified
- Apr 2020
- First submitted
- 19 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
- ClinicalTrials.gov ID
- NCT04408534
- Acronym / sponsor ID
- 2020-A01183-36
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 29 May 2020 (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.
This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea
Detailed description
This study is a cross over randomized study which aims to compare the effect of 2 modes of noninvasive ventilation on the occurence of central apnea, as measured by electrical activity of the diaphragm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Active comparator | Other: mode of noninvasive ventilationPatients receive continuous positive airway pressure as a mode of noninvasive ventilation |
| bilevel positive airway pressure | Experimental | Other: mode of noninvasive ventilationPatients receive bilevel positive airway pressure as a mode of noninvasive ventilation |
Who may qualify
- Ages
- 3 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children born at gestational age > 36 weeks gestation
- Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
- Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia < 80 / min, 2/Associated with desaturation < 85% or 3/Duration more than 10 seconds
- Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)
Key exclusion criteria (5 listed)
- With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
- Ventilated in NIV for more than 48 hours before inclusion
- Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
- Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
- Patient not affiliated to health care insurance
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 |
|---|---|---|
| mode of noninvasive ventilationadministration of during 3 hours each 4 cycles | Other | bilevel positive airway pressure, continuous positive airway pressure |
Primary outcome
Apnea
Time frame: Up to 12 hours
Number of apnea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing mode of noninvasive ventilation in people with Bronchiolitis, run by University Hospital, Grenoble.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Apnea (time frame: Up to 12 hours). 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 29 May 2020.