Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Not Applicable

• Conditions: Bronchiolitis

• Registration Number: NCT04408534
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29
• Study Start: 2020-12-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Apnea	Up to 12 hours	Number of apnea