Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04408534

Enrollment

Registered

2020-05-29

Start date

2020-12-01

Completion date

2022-03-31

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

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

Interventions

OTHERmode of noninvasive ventilation

administration of during 3 hours each 4 cycles

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Apnea	Up to 12 hours	Number of apnea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026