Clinical trial NCT03738501: Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis
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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Viral Bronchiolitis
Keywords: Food intake
Chest physiotherapy
Sleep
Respiratory Distress
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Food ingestion
timeFrame: 24 hours following intervention
Secondary outcomes:
measure: Sleep quality
timeFrame: 24 hours following intervention
measure: Sleep quality
timeFrame: 24 hours following intervention
measure: Oxygen saturation
timeFrame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
measure: Respiratory rate
timeFrame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
measure: Heart Rate
timeFrame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
measure: Respiratory Distress
timeFrame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Groupe Hospitalier Du Havre
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Pascal Le Roux, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.