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

Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Viral Bronchiolitis
• Intervention / Treatment: Other: Chest physiotherapy with SET; Other: Standard Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Havre, France, 76290
    • Groupe Hospitalier Du Havre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food ingestion	Total Food ingestion within 24 hours after intervention measured by nurses or parents	24 hours following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Total Sleep Time	24 hours following intervention
Sleep quality	Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep	24 hours following intervention
Oxygen saturation	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Respiratory rate	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Heart Rate	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
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.	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre
• Investigators: Principal Investigator: Pascal Le Roux, MD, Groupe Hospitalier Du Havre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Sleep; Food intake; Chest physiotherapy; Respiratory Distress
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral
• Other Study ID Numbers: 2018-A01864-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No