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

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ClinicalTrials.gov Identifier: NCT03738501
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yann Combret, Groupe Hospitalier du Havre

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.

Condition or disease Intervention/treatment Phase
Acute Viral Bronchiolitis Other: Chest physiotherapy with SET Other: Standard Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : August 15, 2020

Arm Intervention/treatment
Experimental: Chest physiotherapy with SET
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)
Other: Chest physiotherapy with SET
Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)

Other: Standard Treatment
Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)

Active Comparator: Standard treatment
Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.
Other: Standard Treatment
Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)




Primary Outcome Measures :
  1. Food ingestion [ Time Frame: 24 hours following intervention ]
    Total Food ingestion within 24 hours after intervention measured by nurses or parents


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 24 hours following intervention ]
    Total Sleep Time

  2. Sleep quality [ Time Frame: 24 hours following intervention ]
    Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep

  3. Oxygen saturation [ Time Frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention ]
    Pulse oximetry monitoring

  4. Respiratory rate [ Time Frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention ]
    Pulse oximetry monitoring

  5. Heart Rate [ Time Frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention ]
    Pulse oximetry monitoring

  6. Respiratory Distress [ Time Frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention ]
    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.



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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738501


Contacts
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Contact: Yann Combret, PT, MSc +33786952577 yann.combret@gmail.com
Contact: Mélody Couet, PT +33611556223 couetmelody@gmail.com

Locations
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France
Groupe Hospitalier Du Havre Recruiting
Le Havre, France, 76290
Contact: Yann Combret, PT, MSc, PhD Cdt    0786952577    yann.combret@gmail.com   
Contact: Pascal Le Roux, MD         
Sponsors and Collaborators
Groupe Hospitalier du Havre
Investigators
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Principal Investigator: Pascal Le Roux, MD Groupe Hospitalier du Havre

Publications:
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Responsible Party: Yann Combret, Physiotherapist, MSc, PhD Candidate, Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT03738501    
Other Study ID Numbers: 2018-A01864-51
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yann Combret, Groupe Hospitalier du Havre:
Food intake
Chest physiotherapy
Sleep
Respiratory Distress
Additional relevant MeSH terms:
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Bronchiolitis, Viral
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases