Status:
UNKNOWN
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Bronchiolitis
Eligibility:
All Genders
3-6 years
Phase:
NA
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 diaphrag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04408534
Start Date
December 1 2020
End Date
March 31 2022
Last Update
May 29 2020
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