Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

— BRONCHIOL-EAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738501
• Other study ID #: 2018-A01864-51
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2022
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Other:
• Chest physiotherapy with SET
Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)
• Standard Treatment
Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)

Locations

Country	Name	City	State
France	Groupe Hospitalier Du Havre	Le Havre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: Pediatrics. 2015 Oct;136(4):782. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food ingestion	Total Food ingestion within 24 hours after intervention measured by nurses or parents	24 hours following intervention
Secondary	Sleep quality	Total Sleep Time	24 hours following intervention
Secondary	Sleep quality	Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep	24 hours following intervention
Secondary	Oxygen saturation	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Secondary	Respiratory rate	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Secondary	Heart Rate	Pulse oximetry monitoring	Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Secondary	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