CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 452 enrolled / 452 target
Drug / intervention
Supine position (SP) +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976895
NCT03976895N/ACompletedOn Track (6.9/mo)Completion was 30mo ago

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

Hospices Civils de Lyon·interventional·Posted Jun 6, 2019·Updated Jun 25, 2026

In Brief

A clinical study evaluating Supine position (SP) and Prone position (PP) for Acute Viral Bronchiolitis. Completed, enrolled 452 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartJan 13, 2021
Primary CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.1 years ago

Arms & Interventions

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

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.

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.