Acute Viral BronchiolitisPROPOSITISNCT03976895
Prone Position in Acute Bronchiolitis
A study testing Supine position (SP) and Prone position (PP) in people with Acute Viral Bronchiolitis, run by Hospices Civils de Lyon at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- Supine position (SP) and Prone position (PP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 16 sitesFrance
- Study dates
- 13 Jan 2021to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon
Bron, 69500
CHU de Caen, Service de réanimation et surveillance continue pédiatrique
Caen, 14000
CH CHAMBERY Unité de surveillance continue pédiatrique
Chambéry, 73000
CH CLERMONT FERRAND Service de réanimation néonatal et pédiatrique, CHU Estaing
Clermont-Ferrand, 63003
Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique
Dijon, 21079
CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique
Épagny, 74370
CH VILLEFRANCHE Service de pédiatrie néonatologie
Gleizé, 69400
CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant
La Tronche, 38700
CHU MONTPELLIER Service de réanimation pédiatrique
Montpellier, 34295
CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant
Nantes, 44093
CHU LENVAL NICE Service de réanimation pédiatrique
Nice, 06200
Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales
Paris, 75015
CHU SAINT-ETIENNE Service de réanimation pédiatrique
Saint-Priest-en-Jarez, 42270
Hôpital Hautepierre CHU de Strasbourg Service de réanimation pédiatrique spécialisée
Strasbourg, 67098
Hôpital Clocheville Service de réanimation pédiatrique et d'USC médico-chirurgicale CHRU Tours
Tours, 37044
CRHU Nancy Réanimation Pédiatrique Spécialisée
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis
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.
Read more
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
- Being tested
- Supine position (SP), Prone position (PP)
- Keywords
- viral bronchiolitis, Prone position, high flow nasal cannula, noninvasive ventilation, Randomized controlled trial
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine position (SP)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Supine position (SP) | Other | Supine position (SP) combined with HFNC Receives: Procedure: Supine position (SP) |
| Prone position (PP) | Experimental | Prone position (SP) combined with HFNC Receives: Procedure: Prone position (PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (10)
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
Measured: 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
Measured: 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.
Measured: maximum 3 months
Length of stay
Length of stay in days. This data will be collected at hospital discharge.
Measured: maximum 3 months
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
Measured: 2 hours
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
Measured: 12 hours
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Measured: 24 hours
Tolerance evaluation
Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition.
This data will be collected at critical care unit discharge.
Measured: 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
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start13 Jan 2021
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976895
- Sponsor's protocol ID
- 69HCL19_0333
- Acronym
- PROPOSITIS
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2019
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Jul 28;336(4):315-322. doi: 10.1001/jama.2026.11078.
PubMed 42307570
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT03976895
- Acronym / sponsor ID
- PROPOSITIS / 69HCL19_0333
- Conditions
- Acute Viral Bronchiolitis
- Keywords
- viral bronchiolitis, Prone position, high flow nasal cannula, noninvasive ventilation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position (SP) | Other | Procedure: Supine position (SP)Supine position (SP) combined with HFNC |
| Prone position (PP) | Experimental | Procedure: Prone position (PP)Prone position (SP) combined with HFNC |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine position (SP)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. | Procedure or surgery | Supine position (SP) |
| Prone position (PP)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. | Procedure or surgery | Prone position (PP) |
Primary outcome
Proportion of ventilated children in each of the 2 groups
Time frame: 3 days
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
10 secondary outcomes
Proportion of failure
Time frame: 3 days
Causes of failure
Time frame: 3 days
Duration of ventilation
Time frame: maximum 3 months
Length of stay
Time frame: maximum 3 months
Oxygenation evaluation
Time frame: 2 hours
Oxygenation evaluation
Time frame: 12 hours
Oxygenation evaluation
Time frame: 24 hours
Tolerance evaluation
Time frame: maximum 3 months
Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours
Time frame: 2 hours
Evaluation of the feasibility of maintaining the position
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 42307570Baudin 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 Jul 28;336(4):315-322. doi: 10.1001/jama.2026.11078.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position (SP) and Prone position (PP) in people with Acute Viral Bronchiolitis, run by Hospices Civils de Lyon at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ventilated children in each of the 2 groups (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.