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Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis (BRONCHIOL-EAT)

Primary Purpose

Acute Viral Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chest physiotherapy with SET
Standard Treatment
Sponsored by
Groupe Hospitalier du Havre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Viral Bronchiolitis focused on measuring Food intake, Chest physiotherapy, Sleep, Respiratory Distress

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children under 12 months
  • hospitalized for bronchiolitis
  • chest physiotherapy prescription
  • bronchial obstruction confirmed by physician and respiratory physiotherapist

Non-inclusion Criteria :

  • children more than 1 year
  • exclusive breastfeeding or enteral feeding
  • prematurity (gestational age < 35 weeks)
  • cardiac, neurological and pulmonary comorbidity
  • continuous oxygen supplementation or ventilatory support
  • chest physiotherapy contraindications

Exclusion Criteria:

  • side effects during chest physiotherapy : bradycardia <100 bpm, oxygen saturation<90%, general state alteration
  • outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization
  • chest physiotherapy cessation according to family request

Sites / Locations

  • Groupe Hospitalier Du Havre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chest physiotherapy with SET

Standard treatment

Arm Description

Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment)

Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.

Outcomes

Primary Outcome Measures

Food ingestion
Total Food ingestion within 24 hours after intervention measured by nurses or parents

Secondary Outcome Measures

Sleep quality
Total Sleep Time
Sleep quality
Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep
Oxygen saturation
Pulse oximetry monitoring
Respiratory rate
Pulse oximetry monitoring
Heart Rate
Pulse oximetry monitoring
Respiratory Distress
Bronchiolitis Severity Score (described by Gajdos et al. as mentioned in the references). The Bronchiolitis Severity Score involves the calculation and addition of three subscores (age-based respiratory rate scale, score of 1-3; retractions, and wheeze scales, both running from 0 to 3). Total score ranges from 1 to 9, with higher scores indicating greater respiratory distress.

Full Information

First Posted
November 8, 2018
Last Updated
December 8, 2022
Sponsor
Groupe Hospitalier du Havre
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1. Study Identification

Unique Protocol Identification Number
NCT03738501
Brief Title
Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis
Acronym
BRONCHIOL-EAT
Official Title
Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier du Havre

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.
Detailed Description
Bronchiolitis is the most common lower respiratory viral infection in infants. Nowadays bronchiolitis is the first reason of children hospitalisation worldwide. Symptoms are based on airway inflammation associated to an increased mucus production and cell necrosis leading to a multifactorial airway obstruction. Recommended treatments are supportive care based on oxygenation and rehydration. Airway clearance techniques represented by chest physiotherapy remain controversial. Considering that bronchiolitis impacts respiratory condition in young infants feeding and sleep may be reduced. Evaluating quality of life represented by feeding and sleep in hospitalized infants may be an important outcome in this population. The investigators hypothesized that chest physiotherapy with SET will improve children's quality of life, especially 24 hours food intake and sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchiolitis
Keywords
Food intake, Chest physiotherapy, Sleep, Respiratory Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest physiotherapy with SET
Arm Type
Experimental
Arm Description
Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment)
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy with SET
Intervention Description
Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)
Primary Outcome Measure Information:
Title
Food ingestion
Description
Total Food ingestion within 24 hours after intervention measured by nurses or parents
Time Frame
24 hours following intervention
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Total Sleep Time
Time Frame
24 hours following intervention
Title
Sleep quality
Description
Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep
Time Frame
24 hours following intervention
Title
Oxygen saturation
Description
Pulse oximetry monitoring
Time Frame
Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Title
Respiratory rate
Description
Pulse oximetry monitoring
Time Frame
Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Title
Heart Rate
Description
Pulse oximetry monitoring
Time Frame
Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Title
Respiratory Distress
Description
Bronchiolitis Severity Score (described by Gajdos et al. as mentioned in the references). The Bronchiolitis Severity Score involves the calculation and addition of three subscores (age-based respiratory rate scale, score of 1-3; retractions, and wheeze scales, both running from 0 to 3). Total score ranges from 1 to 9, with higher scores indicating greater respiratory distress.
Time Frame
Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children under 12 months hospitalized for bronchiolitis chest physiotherapy prescription bronchial obstruction confirmed by physician and respiratory physiotherapist Non-inclusion Criteria : children more than 1 year exclusive breastfeeding or enteral feeding prematurity (gestational age < 35 weeks) cardiac, neurological and pulmonary comorbidity continuous oxygen supplementation or ventilatory support chest physiotherapy contraindications Exclusion Criteria: side effects during chest physiotherapy : bradycardia <100 bpm, oxygen saturation<90%, general state alteration outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization chest physiotherapy cessation according to family request
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Le Roux, MD
Organizational Affiliation
Groupe Hospitalier du Havre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Du Havre
City
Le Havre
ZIP/Postal Code
76290
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25349312
Citation
Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum In: Pediatrics. 2015 Oct;136(4):782.
Results Reference
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PubMed Identifier
20927359
Citation
Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
Results Reference
background
PubMed Identifier
19598273
Citation
Gajdos V, Beydon N, Bommenel L, Pellegrino B, de Pontual L, Bailleux S, Labrune P, Bouyer J. Inter-observer agreement between physicians, nurses, and respiratory therapists for respiratory clinical evaluation in bronchiolitis. Pediatr Pulmonol. 2009 Aug;44(8):754-62. doi: 10.1002/ppul.21016.
Results Reference
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Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

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