Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Study Overview
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Brief Summary
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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
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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

Official Title
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Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: mode of noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous positive airway pressure<br>Patients receive continuous positive airway pressure as a mode of noninvasive ventilation | Other: mode of noninvasive ventilation<br>* administration of during 3 hours each 4 cycles<br>|
| Experimental: bilevel positive airway pressure<br>Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation | Other: mode of noninvasive ventilation<br>* administration of during 3 hours each 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea | Number of apnea | Up to 12 hours |