Clinical trial NCT03976895: Prone Position in Acute Bronchiolitis
Official title: Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Viral Bronchiolitis
Keywords: viral bronchiolitis
Prone position
high flow nasal cannula
noninvasive ventilation
Randomized controlled trial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 452
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

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
* 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

Primary outcomes:
measure: Proportion of ventilated children in each of the 2 groups
timeFrame: 3 days
Secondary outcomes:
measure: Proportion of failure
timeFrame: 3 days
measure: Causes of failure
timeFrame: 3 days
measure: Duration of ventilation
timeFrame: maximum 3 months
measure: Length of stay
timeFrame: maximum 3 months
measure: Oxygenation evaluation
timeFrame: 2 hours
measure: Oxygenation evaluation
timeFrame: 12 hours
measure: Oxygenation evaluation
timeFrame: 24 hours
measure: Tolerance evaluation
timeFrame: maximum 3 months
measure: Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours
timeFrame: 2 hours
measure: Evaluation of the feasibility of maintaining the position
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bron
country: France
facility: Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon
city: Caen
country: France
facility: CHU de Caen, Service de réanimation et surveillance continue pédiatrique
city: Chambéry
country: France
facility: CH CHAMBERY Unité de surveillance continue pédiatrique
city: Dijon
country: France
facility: Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique
city: Gleizé
country: France
facility: CH VILLEFRANCHE Service de pédiatrie néonatologie
city: La Tronche
country: France
facility: CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant
city: Montpellier
country: France
facility: CHU MONTPELLIER Service de réanimation pédiatrique
city: Nantes
country: France
facility: CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant
city: Nice
country: France
facility: CHU LENVAL NICE Service de réanimation pédiatrique
city: Paris
country: France
facility: Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales
city: Saint-Priest-en-Jarez
country: France
facility: CHU SAINT-ETIENNE Service de réanimation pédiatrique
city: Vandœuvre-lès-Nancy
country: France
facility: CRHU Nancy Réanimation Pédiatrique Spécialisée
city: Épagny
country: France
facility: CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique
Study officials:
References: