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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest physiotherapy with SET | Experimental | 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) |
|
| Standard treatment | Active Comparator | Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest physiotherapy with SET | Other | Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Food ingestion | Total Food ingestion within 24 hours after intervention measured by nurses or parents | 24 hours following intervention |
| 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 |
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Inclusion Criteria:
Non-inclusion Criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Le Roux, MD | Groupe Hospitalier du Havre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Du Havre | Le Havre | 76290 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25349312 | Background | 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. | |
| 20927359 |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C513473 | SET protein, human |
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| Standard Treatment | Other | Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices) |
|
| 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 |
| Background |
| 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. |
| 19598273 | Background | 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. |
| 39334411 | Derived | 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. |
| 37010196 | Derived | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |