An interventional study of Supine position (SP) and Prone position (PP) in Acute Viral Bronchiolitis, sponsored by Hospices Civils de Lyon. Completed at 16 sites in France. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 452 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supine position (SP) combined with HFNC
Procedure: Supine position (SP)
Prone position (SP) combined with HFNC
Procedure: Prone position (PP)
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.
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.
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
Time frame: 3 days
Proportion of failure
Failure is defined as: * HFNC failure (composite failure criterion validated by an independent committee) * worsening of mWCAS score ≥ 1 point * hypercapnic acidosis (pH ≤7.30 and pCO2≥8kPa) * significant apnea (apnea with desaturation \<90% and / or bradycardia \<90/min) Anytime over the first 3 days after inclusion
Time frame: 3 days
Causes of failure
Failure is defined as: * HFNC failure (composite failure criterion validated by an independent committee) * worsening of mWCAS score ≥ 1 point * hypercapnic acidosis (pH ≤7.30 and pCO2≥8kPa) * significant apnea (apnea with desaturation \<90% and / or bradycardia \<90/min) Anytime over the first 3 days after inclusion
Time frame: 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.
Time frame: maximum 3 months
Length of stay
Length of stay in days. This data will be collected at hospital discharge.
Time frame: maximum 3 months
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
Time frame: 2 hours
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
Time frame: 12 hours
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Time frame: 24 hours
Tolerance evaluation
Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition. This data will be collected at critical care unit discharge.
Time frame: 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: * Face: Relaxed=0 to Permanent tightness or prostrate face,frozen or purple face=3 * Body: Relaxed=0 to Permanent agitation,tightness of extremities and stiffness of limbs or very poor and limited motor skills with fixed body=3 * Sleep:Easily, extended and calm=0 to No sleep=3 * Relationship:Smile to the angels,smile answer,attentive to the listening=0 to Refuses contact,no relationship possible,howl or moan without any stimulation=3 * Comfort: Do not need comfort=0 to Inconsolable,desperate sucking=3
Time frame: 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
Time frame: 48 hours
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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