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COMPLETED
NCT03976895
NA

Prone Position in Acute Bronchiolitis

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support. Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU. In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis. Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.

Official title: Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis

Key Details

Gender

All

Age Range

Any - 6 Months

Study Type

INTERVENTIONAL

Enrollment

452

Start Date

2021-01-13

Completion Date

2023-12-11

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

PROCEDURE

Supine position (SP)

Infants under high flow nasal cannula (HFNC) will be positioned in the supine position. Patients may be positioned temporarily in lateral position between periods of supine position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.

PROCEDURE

Prone position (PP)

Infants under high flow nasal cannula (HFNC) will be placed in the prone position during at least 24 hours over the first 48 hours. The positioning will be standardized (chest on the bed plan and abdomen cleared) and children should be placed in the prone position immediately after randomization. Patients may be positioned temporarily in lateral position between periods of prone position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.

Locations (16)

Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon

Bron, France

CHU de Caen, Service de réanimation et surveillance continue pédiatrique

Caen, France

CH CHAMBERY Unité de surveillance continue pédiatrique

Chambéry, France

CH CLERMONT FERRAND Service de réanimation néonatal et pédiatrique, CHU Estaing

Clermont-Ferrand, France

Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique

Dijon, France

CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique

Épagny, France

CH VILLEFRANCHE Service de pédiatrie néonatologie

Gleizé, France

CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant

La Tronche, France

CHU MONTPELLIER Service de réanimation pédiatrique

Montpellier, France

CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant

Nantes, France

CHU LENVAL NICE Service de réanimation pédiatrique

Nice, France

Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales

Paris, France

CHU SAINT-ETIENNE Service de réanimation pédiatrique

Saint-Priest-en-Jarez, France

Hôpital Hautepierre CHU de Strasbourg Service de réanimation pédiatrique spécialisée

Strasbourg, France

Hôpital Clocheville Service de réanimation pédiatrique et d'USC médico-chirurgicale CHRU Tours

Tours, France

CRHU Nancy Réanimation Pédiatrique Spécialisée

Vandœuvre-lès-Nancy, France