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Completed

NCT Number: NCT03738501

Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

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.

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Key information

Conditions

Acute Viral Bronchiolitis Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Du Havre

Le Havre, 76290, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest physiotherapy with SET

Other

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

standard treatment

Other

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

Primary outcomes

  1. Food ingestion

    Time frame: 24 hours following intervention

    Total Food ingestion within 24 hours after intervention measured by nurses or parents

Secondary outcomes

  1. Sleep quality

    Time frame: 24 hours following intervention

    Total Sleep Time

  2. Sleep quality

    Time frame: 24 hours following intervention

    Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep

  3. Oxygen saturation

    Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

    Pulse oximetry monitoring

  4. Respiratory rate

    Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

    Pulse oximetry monitoring

  5. Heart Rate

    Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

    Pulse oximetry monitoring

  6. Respiratory Distress

    Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

    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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

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

Acronym: BRONCHIOL-EAT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2018
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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