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Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

NCT ID: NCT04408534

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-03-31

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

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous positive airway pressure

Patients receive continuous positive airway pressure as a mode of noninvasive ventilation

Group Type ACTIVE_COMPARATOR

mode of noninvasive ventilation

Intervention Type OTHER

administration of during 3 hours each 4 cycles

bilevel positive airway pressure

Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation

Group Type EXPERIMENTAL

mode of noninvasive ventilation

Intervention Type OTHER

administration of during 3 hours each 4 cycles

Interventions

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mode of noninvasive ventilation

administration of during 3 hours each 4 cycles

Intervention Type OTHER

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
Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2020-A01183-36

Identifier Type: -

Identifier Source: org_study_id