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Stomach lying may cut breathing support needs in sick infants

NCT ID NCT03976895

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether placing infants under 6 months with moderate to severe bronchiolitis on their stomachs (prone position) while on high-flow oxygen could reduce the need for more intensive breathing support. A total of 452 infants in critical care were randomly assigned to lie on their stomachs or backs. The goal was to see if stomach positioning lowered the rate of needing non-invasive or invasive ventilation within the first three days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prone position (lying on stomach)
What this could lead to
If effective, placing infants on their stomachs during high-flow oxygen therapy could reduce the need for more invasive breathing support.
What could go wrong
This is a completed study, but the benefit may depend on how strictly the positioning protocol is followed. Results may not apply to all infants or hospital settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

452 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

acute bronchiolitis Bronchiolitis, Viral

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute viral bronchiolitis

Contacts and locations

Locations

  • CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique

    Épagny, 74370, France

  • CH CHAMBERY Unité de surveillance continue pédiatrique

    Chambéry, 73000, France

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

    Clermont-Ferrand, 63003, France

  • CH VILLEFRANCHE Service de pédiatrie néonatologie

    Gleizé, 69400, France

  • CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant

    La Tronche, 38700, France

  • CHU LENVAL NICE Service de réanimation pédiatrique

    Nice, 06200, France

  • CHU MONTPELLIER Service de réanimation pédiatrique

    Montpellier, 34295, France

  • CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant

    Nantes, 44093, France

  • CHU SAINT-ETIENNE Service de réanimation pédiatrique

    Saint-Priest-en-Jarez, 42270, France

  • CHU de Caen, Service de réanimation et surveillance continue pédiatrique

    Caen, 14000, France

  • CRHU Nancy Réanimation Pédiatrique Spécialisée

    Vandœuvre-lès-Nancy, 54500, France

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

    Tours, 37044, France

  • Hôpital Hautepierre CHU de Strasbourg Service de réanimation pédiatrique spécialisée

    Strasbourg, 67098, France

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

    Paris, 75015, France

  • Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique

    Dijon, 21079, France

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

    Bron, 69500, France

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