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Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

NCT ID: NCT03738501

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2022-12-08

Brief Summary

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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

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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.

Conditions

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Acute Viral Bronchiolitis

Keywords

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Food intake Chest physiotherapy Sleep Respiratory Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Chest physiotherapy with SET

Intervention Type OTHER

Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)

Standard Treatment

Intervention Type OTHER

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

Standard treatment

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

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

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

Interventions

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Chest physiotherapy with SET

Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)

Intervention Type OTHER

Standard Treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier du Havre

OTHER

Sponsor Role lead

Responsible Party

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Yann Combret

Physiotherapist, MSc, PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pascal Le Roux, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier du Havre

Locations

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Groupe Hospitalier Du Havre

Le Havre, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25349312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20927359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19598273 (View on PubMed)

Combret Y, Machefert M, Couet M, Bonnevie T, Gravier FE, Gillot T, Le Roux P, Hilfiker R, Medrinal C, Prieur G. Effect of a prolonged slow expiration technique on 24-h food intake in children hospitalized for moderate bronchiolitis: a randomized controlled trial. Ital J Pediatr. 2024 Sep 27;50(1):196. doi: 10.1186/s13052-024-01770-2.

Reference Type DERIVED
PMID: 39334411 (View on PubMed)

Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

Reference Type DERIVED
PMID: 37010196 (View on PubMed)

Other Identifiers

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2018-A01864-51

Identifier Type: -

Identifier Source: org_study_id