Prone Position in Acute Bronchiolitis

NCT03976895 | Completed

• 1 other identifier: 69HCL19_0333
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Acute Viral Bronchiolitis

Keywords

viral bronchiolitis; Prone position; high flow nasal cannula; noninvasive ventilation; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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): * Clinical aggravation defined by an increase ≥ 1 point of the m-WCAS score * Persistence of hypercapnic acidosis with pH ≤7.30 and pCO2≥ 8 kPa or FiO2\> 60% under HFNC at 2 L/kg/min * More than 3 significant apneas per hour (apnea with desaturation \<90% and / or bradycardia \<90 / min) * Consciousness disorder Anytime over the first 3 days after inclusion

  3 days

Secondary Outcomes (10)

• Proportion of failure

  3 days

• Causes of failure

  3 days

• Duration of ventilation

  maximum 3 months

• Length of stay

  maximum 3 months

• Oxygenation evaluation

  2 hours

Study Arms (2)

Supine position (SP)

OTHER

Supine position (SP) combined with HFNC

Procedure: Supine position (SP)

Prone position (PP)

EXPERIMENTAL

Prone position (SP) combined with HFNC

Procedure: Prone position (PP)

Interventions

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.

Prone position (PP)

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.

Supine position (SP)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant under 6 months
• Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
• With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
• m-WCAS score ≥ 3 and / or hypercapnic acidosis with pH \<7.35 and pCO2\> 50mmHg (6.7 kPa)
• Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file (with deferred written consent).

You may not qualify if:

• Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH \<7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2\> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
• Patient already positioned in the prone position before randomization for more than 3 hours
• Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
• Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
• Patient who is not affiliated (or does not benefit from) to a national social security system

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (16)

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

Bron, 69500, France

Location

CHU de Caen, Service de réanimation et surveillance continue pédiatrique

Caen, 14000, France

Location

CH CHAMBERY Unité de surveillance continue pédiatrique

Chambéry, 73000, France

Location

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

Clermont-Ferrand, 63003, France

Location

Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique

Dijon, 21079, France

Location

CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique

Épagny, 74370, France

Location

CH VILLEFRANCHE Service de pédiatrie néonatologie

Gleizé, 69400, France

Location

CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant

La Tronche, 38700, France

Location

CHU MONTPELLIER Service de réanimation pédiatrique

Montpellier, 34295, France

Location

CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant

Nantes, 44093, France

Location

CHU LENVAL NICE Service de réanimation pédiatrique

Nice, 06200, France

Location

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

Paris, 75015, France

Location

CHU SAINT-ETIENNE Service de réanimation pédiatrique

Saint-Priest-en-Jarez, 42270, France

Location

Hôpital Hautepierre CHU de Strasbourg Service de réanimation pédiatrique spécialisée

Strasbourg, 67098, France

Location

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

Tours, 37044, France

Location

CRHU Nancy Réanimation Pédiatrique Spécialisée

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Bronchiolitis, Viral

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: January 13, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)