Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis (BRONCHIO-DV)

Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.

Study Overview

• Status: Completed
• Conditions: Severe Bronchiolitis
• Intervention / Treatment: Procedure: Prone then supine position; Procedure: Supine then Prone position

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infant < 6 months
• Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France
• With severe acute viral bronchiolitis requiring ventilatory support (mWCAS > 4 and/or and or FiO2> 40% and/or hypercapnic acidosis (pH<7.30 and/or pCO2>8 kPa))
• Signed informed consent by the two parents or the owner of parental authority

Exclusion Criteria:

• Chronic respiratory, neuromuscular, ENT or cardiac disease
• Contraindication for placement of esophageal probe (esophageal surgery, varices, …)
• Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, …)
• Children not affiliated to a social security scheme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRONE-Supine; We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).	Procedure: Prone then supine position; One hour in prone position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash out ) and one hour in supine position with CPAP (+7 cmH2O)
Experimental: SUPINE - Prone; We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).	Procedure: Supine then Prone position; One hour in supine position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash-out) and one hour in prone position with CPAP (+7 cmH2O)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work of breathing	The primary outcome is the work of breathing (WOB) estimated by the mean on 100 breaths of the esophageal and trans-diaphragmatic Pressure-Time Product (PTP) at the end of the first hour.	60 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrinsic PEEP	Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation	60 min
Inspiratory:Expiratory Time Ratio	Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio	60 min
Heart rate	Evolution of the clinical and oxygenation parameter within the first hour in each position.	60 min
Respiratory rate	Evolution of the clinical and oxygenation parameters within the first hour in each position.	60 min
SPO2	Evolution of the clinical and oxygenation parameters within the first hour in each position.	60 min
Transcutaneous CO2	Evolution of the clinical and oxygenation parameters within the first hour in each position.	60 min
EDIN score (neonatal pain and discomfort scale)		60 min

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimated): November 11, 2015

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prone position; work of breathing; Children.; acute viral bronchiolitis; syncytial virus; intrinsic PEEP
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Insufficiency; Bronchitis; Bronchiolitis; Positive-Pressure Respiration, Intrinsic
• Other Study ID Numbers: 69HCL15_0430