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Prone Position in Acute Bronchiolitis (PROPOSITIS)

Primary Purpose

Acute Viral Bronchiolitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supine position (SP)
Prone position (PP)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Viral Bronchiolitis focused on measuring viral bronchiolitis, Prone position, high flow nasal cannula, noninvasive ventilation, Randomized controlled trial

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de LyonRecruiting
  • CHU de Caen, Service de réanimation et surveillance continue pédiatrique
  • CH CHAMBERY Unité de surveillance continue pédiatriqueRecruiting
  • Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique
  • CH VILLEFRANCHE Service de pédiatrie néonatologieRecruiting
  • CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple EnfantRecruiting
  • CHU MONTPELLIER Service de réanimation pédiatriqueRecruiting
  • CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfantRecruiting
  • CHU LENVAL NICE Service de réanimation pédiatriqueRecruiting
  • Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicalesRecruiting
  • CHU SAINT-ETIENNE Service de réanimation pédiatriqueRecruiting
  • CRHU Nancy Réanimation Pédiatrique Spécialisée
  • CH ANNECY GENEVOIS Unité de surveillance continue pédiatriqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Supine position (SP)

Prone position (PP)

Arm Description

Supine position (SP) combined with HFNC

Prone position (SP) combined with HFNC

Outcomes

Primary Outcome Measures

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 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

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
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
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.
Length of stay
Length of stay in days. This data will be collected at hospital discharge.
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
Oxygenation evaluation
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Tolerance evaluation
Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition. This data will be collected at critical care unit discharge.
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
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

Full Information

First Posted
June 3, 2019
Last Updated
October 20, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03976895
Brief Title
Prone Position in Acute Bronchiolitis
Acronym
PROPOSITIS
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchiolitis
Keywords
viral bronchiolitis, Prone position, high flow nasal cannula, noninvasive ventilation, Randomized controlled trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supine position (SP)
Arm Type
Other
Arm Description
Supine position (SP) combined with HFNC
Arm Title
Prone position (PP)
Arm Type
Experimental
Arm Description
Prone position (SP) combined with HFNC
Intervention Type
Procedure
Intervention Name(s)
Supine position (SP)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prone position (PP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of ventilated children in each of the 2 groups
Description
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
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Proportion of failure
Description
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
Time Frame
3 days
Title
Causes of failure
Description
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
Time Frame
3 days
Title
Duration of ventilation
Description
Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours. This data will be collected at critical care unit discharge.
Time Frame
maximum 3 months
Title
Length of stay
Description
Length of stay in days. This data will be collected at hospital discharge.
Time Frame
maximum 3 months
Title
Oxygenation evaluation
Description
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
Time Frame
2 hours
Title
Oxygenation evaluation
Description
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
Time Frame
12 hours
Title
Oxygenation evaluation
Description
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Time Frame
24 hours
Title
Tolerance evaluation
Description
Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition. This data will be collected at critical care unit discharge.
Time Frame
maximum 3 months
Title
Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours
Description
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
Time Frame
2 hours
Title
Evaluation of the feasibility of maintaining the position
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent BAUDIN, Dr
Phone
04 72 12 97 35
Ext
+33
Email
florent.baudin@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tiphanie GINHOUX
Phone
04 27 85 77 23
Ext
+33
Email
tiphanie.ginhoux@chu-lyon.fr
Facility Information:
Facility Name
Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent BAUDIN, Dr
Phone
04 72 12 97 35
Ext
+33
Email
florent.baudin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Tiphanie GINHOUX
Phone
04 27 85 77 23
Ext
+33
Email
tiphanie.ginhoux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Florent BAUDIN, Dr
Facility Name
CHU de Caen, Service de réanimation et surveillance continue pédiatrique
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BROSSIER David
Email
brossier-d@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
BROSSIER David
Facility Name
CH CHAMBERY Unité de surveillance continue pédiatrique
City
Chambéry
ZIP/Postal Code
73000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne PAGET
Phone
04 79 96 61 60
Ext
+33
Email
Corinne.Paget@ch-metropole-savoie.fr
Facility Name
Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NALLET-AMATE Megan
Email
megan.nallet-amate@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
NALLET-AMATE Megan
Facility Name
CH VILLEFRANCHE Service de pédiatrie néonatologie
City
Gleizé
ZIP/Postal Code
69400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie TOCHON TEIXEIRA
Phone
04 74 09 28 39
Ext
+33
Email
MTochon@lhopitalnordouest.fr
Facility Name
CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MORTAMET
Phone
04 76 76 55 03
Ext
+33
Email
gmortamet@chu-grenoble.fr
Facility Name
CHU MONTPELLIER Service de réanimation pédiatrique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe MILESI
Phone
04 67 33 66 09
Ext
+33
Email
c-milesi@chu-montpellier.fr
Facility Name
CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Eudes PILOQUET
Email
piloquet.jeaneudes@gmail.com
Facility Name
CHU LENVAL NICE Service de réanimation pédiatrique
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael AFFANETI
Phone
04 92 03 04 08
Ext
+33
Email
afanetti.m@pediatrie-chulenval-nice.fr
Facility Name
Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain RENOLLEAU
Phone
01 44 49 56 67
Ext
+33
Email
sylvain.renolleau@aphp.fr
Facility Name
CHU SAINT-ETIENNE Service de réanimation pédiatrique
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BARRIERE
Phone
04 77 82 83 85
Ext
+33
Email
francois.barriere@chu-st-etienne.fr
Facility Name
CRHU Nancy Réanimation Pédiatrique Spécialisée
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WIEDEMANN Arnaud
Email
a.wiedemann-fode@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
WIEDEMANN Arnaud
Facility Name
CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique
City
Épagny
ZIP/Postal Code
74370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence JARASSE
Phone
04 50 63 63 24
Ext
+33
Email
cjarrasse@ch-annecygenevois.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Prone Position in Acute Bronchiolitis

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