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NCT04408534 Clinical Trial

Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Bronchiolitis Clinical Trial

Official title:
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04408534
Other study ID # 2020-A01183-36
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date March 31, 2022

Study information
Verified date April 2020
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• mode of noninvasive ventilation
administration of during 3 hours each 4 cycles

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea Number of apnea Up to 12 hours
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