Prone Position in Acute Bronchiolitis

Not Applicable

• Conditions: Acute Viral Bronchiolitis
• Interventions: Procedure: Prone position (PP); Procedure: Supine position (SP)

• Registration Number: NCT03976895
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Study Start: 2021-01-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 452

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone position (PP)	Prone position (PP)	Prone position (SP) combined with HFNC
Supine position (SP)	Supine position (SP)	Supine position (SP) combined with HFNC

Primary Outcome Measures

Name	Time	Method
Proportion of ventilated children in each of the 2 groups	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 2 significant apneas per hour (apnea with desaturation \<90% and / or bradycardia \<90 / min); * Consciousness disorder; Anytime over the first 3 days after inclusion

Secondary Outcome Measures

Name	Time	Method
Causes of failure	3 days	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
Length of stay	maximum 3 months	Length of stay in days. This data will be collected at hospital discharge.
Duration of ventilation	maximum 3 months	Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours.; This data will be collected at critical care unit discharge.
Oxygenation evaluation	24 hours	Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours	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
Proportion of failure	3 days	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
Evaluation of the feasibility of maintaining the position	48 hours	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
Tolerance evaluation	maximum 3 months	Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition.; This data will be collected at critical care unit discharge.

Trial Locations

Locations (13)

CH VILLEFRANCHE Service de pédiatrie néonatologie; 🇫🇷 Gleizé, France

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

Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique; 🇫🇷 Dijon, France

CH CHAMBERY Unité de surveillance continue pédiatrique; 🇫🇷 Chambéry, France

CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant; 🇫🇷 La Tronche, 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

CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique; 🇫🇷 Épagny, France

CHU MONTPELLIER Service de réanimation pédiatrique; 🇫🇷 Montpellier, France

CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant; 🇫🇷 Nantes, France