Back to resultsBilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
Primary Purpose
Bronchiolitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mode of noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
continuous positive airway pressure
bilevel positive airway pressure
Arm Description
Patients receive continuous positive airway pressure as a mode of noninvasive ventilation
Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation
Outcomes
Primary Outcome Measures
Apnea
Number of apnea
Secondary Outcome Measures
Full Information
NCT ID
NCT04408534
First Posted
May 19, 2020
Last Updated
May 25, 2020
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04408534
Brief Title
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
Official Title
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuous positive airway pressure
Arm Type
Active Comparator
Arm Description
Patients receive continuous positive airway pressure as a mode of noninvasive ventilation
Arm Title
bilevel positive airway pressure
Arm Type
Experimental
Arm Description
Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation
Intervention Type
Other
Intervention Name(s)
mode of noninvasive ventilation
Intervention Description
administration of during 3 hours each 4 cycles
Primary Outcome Measure Information:
Title
Apnea
Description
Number of apnea
Time Frame
Up to 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
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