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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine position (SP) | Other | Supine position (SP) combined with HFNC |
|
| Prone position (PP) | Experimental | Prone position (SP) combined with HFNC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine position (SP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of ventilated children in each of the 2 groups | Indications for the use of ventilation (invasive or non-invasive ventilation) will be standardized in both groups (based on the interregional protocol for the management of bronchiolitis):
Anytime over the first 3 days after inclusion | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of failure | Failure is defined as:
Anytime over the first 3 days after inclusion | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon | Bron | 69500 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42307570 | Result | Baudin F, Pouyau R, Subtil F, Jarrasse C, Tochon M, Afanetti M, Milesi C, Piloquet JE, Mortamet G, Nallet Amate M, Launay V, Cour Andlauer F, Roche S, Levy M, Rambaud J, Portefaix A, Javouhey E; PROPOSITIS Investigators. Prone Positioning in Infants With Acute Bronchiolitis: The PROPOSITIS Randomized Clinical Trial. JAMA. 2026 Jun 17. doi: 10.1001/jama.2026.11078. Online ahead of print. |
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| ID | Term |
|---|---|
| D001990 | Bronchiolitis, Viral |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016683 | Supine Position |
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Prone position (PP) | Procedure | 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. |
|
| Causes of failure | Failure is defined as:
Anytime over the first 3 days after inclusion | 3 days |
| Duration of ventilation | Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours. This data will be collected at critical care unit discharge. | maximum 3 months |
| Length of stay | Length of stay in days. This data will be collected at hospital discharge. | maximum 3 months |
| Oxygenation evaluation | Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2. | 2 hours |
| Oxygenation evaluation | Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12. | 12 hours |
| Oxygenation evaluation | Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24. | 24 hours |
| Tolerance evaluation | Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition. This data will be collected at critical care unit discharge. | maximum 3 months |
| Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours | Scale ranges to 0 from 15 and is a combination of criteria:
| 2 hours |
| Evaluation of the feasibility of maintaining the position | Proportion of children in the prone position repositioned definitively in the supine position before performing the cumulative 24 hours of prone position, cumulative hours of prone position in the first 48 hours | 48 hours |
| CHU de Caen, Service de réanimation et surveillance continue pédiatrique |
| Caen |
| 14000 |
| France |
| CH CHAMBERY Unité de surveillance continue pédiatrique | Chambéry | 73000 | France |
| CH CLERMONT FERRAND Service de réanimation néonatal et pédiatrique, CHU Estaing | Clermont-Ferrand | 63003 | France |
| Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique | Dijon | 21079 | France |
| CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique | Épagny | 74370 | France |
| CH VILLEFRANCHE Service de pédiatrie néonatologie | Gleizé | 69400 | France |
| CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant | La Tronche | 38700 | France |
| CHU MONTPELLIER Service de réanimation pédiatrique | Montpellier | 34295 | France |
| CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant | Nantes | 44093 | France |
| CHU LENVAL NICE Service de réanimation pédiatrique | Nice | 06200 | France |
| Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales | Paris | 75015 | France |
| CHU SAINT-ETIENNE Service de réanimation pédiatrique | Saint-Priest-en-Jarez | 42270 | France |
| Hôpital Hautepierre CHU de Strasbourg Service de réanimation pédiatrique spécialisée | Strasbourg | 67098 | France |
| Hôpital Clocheville Service de réanimation pédiatrique et d'USC médico-chirurgicale CHRU Tours | Tours | 37044 | France |
| CRHU Nancy Réanimation Pédiatrique Spécialisée | Vandœuvre-lès-Nancy | 54500 | France |
| D014777 |
| Virus Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |