Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
452 participants
INTERVENTIONAL
2021-01-13
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Supine position (SP)
Supine position (SP) combined with HFNC
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.
Prone position (PP)
Prone position (SP) combined with HFNC
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Patient already positioned in the prone position before randomization
* 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
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon
Bron, , France
CHU de Caen, Service de réanimation et surveillance continue pédiatrique
Caen, , France
CH CHAMBERY Unité de surveillance continue pédiatrique
Chambéry, , France
Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique
Dijon, , France
CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique
Épagny, , France
CH VILLEFRANCHE Service de pédiatrie néonatologie
Gleizé, , France
CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant
La Tronche, , France
CHU MONTPELLIER Service de réanimation pédiatrique
Montpellier, , France
CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant
Nantes, , France
CHU LENVAL NICE Service de réanimation pédiatrique
Nice, , France
Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales
Paris, , France
CHU SAINT-ETIENNE Service de réanimation pédiatrique
Saint-Priest-en-Jarez, , France
CRHU Nancy Réanimation Pédiatrique Spécialisée
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL19_0333
Identifier Type: -
Identifier Source: org_study_id