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Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03738501
Acronym
BRONCHIOL-EAT
Enrollment
42
Registered
2018-11-13
Start date
2019-01-02
Completion date
2022-12-08
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Viral Bronchiolitis

Keywords

Food intake, Chest physiotherapy, Sleep, Respiratory Distress

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.

Interventions

OTHERChest physiotherapy with SET

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

OTHERStandard Treatment

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

Sponsors

Groupe Hospitalier du Havre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Food ingestion24 hours following interventionTotal Food ingestion within 24 hours after intervention measured by nurses or parents

Secondary

MeasureTime frameDescription
Sleep quality24 hours following interventionTotal Sleep Time
Oxygen saturationBefore intervention ; 5 minutes, 30 minutes and 24 hours after interventionPulse oximetry monitoring
Respiratory rateBefore intervention ; 5 minutes, 30 minutes and 24 hours after interventionPulse oximetry monitoring
Heart RateBefore intervention ; 5 minutes, 30 minutes and 24 hours after interventionPulse oximetry monitoring
Respiratory DistressBefore intervention ; 5 minutes, 30 minutes and 24 hours after interventionBronchiolitis 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026