Acute Viral BronchiolitisBRONCHIOL-EATNCT03738501
Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis
A study testing Chest physiotherapy with SET and Standard Treatment in people with Acute Viral Bronchiolitis, run by Groupe Hospitalier du Havre at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- Chest physiotherapy with SET and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- exclusive breastfeeding or enteral feeding
- prematurity (gestational age < 35 weeks)
- cardiac, neurological and pulmonary comorbidity
- continuous oxygen supplementation or ventilatory support
- chest physiotherapy contraindications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study
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.
Read the 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.
- Conditions
- Acute Viral Bronchiolitis
- Being tested
- Chest physiotherapy with SET, Standard Treatment
- Keywords
- Food intake, Chest physiotherapy, Sleep, Respiratory Distress
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy with SETOther
Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)
Standard TreatmentOther
Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Chest physiotherapy with SET; Other: Standard Treatment |
| Standard treatment | Active comparator | Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices. Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food ingestion
Total Food ingestion within 24 hours after intervention measured by nurses or parents
Measured: 24 hours following intervention
Secondary outcomes (6)
Sleep quality
Total Sleep Time
Measured: 24 hours following intervention
Sleep quality
Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep
Measured: 24 hours following intervention
Oxygen saturation
Pulse oximetry monitoring
Measured: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Respiratory rate
Pulse oximetry monitoring
Measured: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Heart Rate
Pulse oximetry monitoring
Measured: 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.
Measured: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start2 Jan 2019
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yann Combret, Groupe Hospitalier du Havre
- Investigators
- Pascal Le Roux, MD, Principal investigator, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738501
- Sponsor's protocol ID
- 2018-A01864-51
- Acronym
- BRONCHIOL-EAT
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2018
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25349312Gajdos 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.
PubMed 20927359Gajdos 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.
PubMed 19598273Combret 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.
PubMed 39334411Roque-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.
PubMed 37010196
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03738501
- Acronym / sponsor ID
- BRONCHIOL-EAT / 2018-A01864-51
- Conditions
- Acute Viral Bronchiolitis
- Keywords
- Food intake, Chest physiotherapy, Sleep, Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest physiotherapy with SET | Experimental | Other: Chest physiotherapy with SET, Other: Standard TreatmentChest 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 | Other: Standard TreatmentMedical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- children under 12 months
- hospitalized for bronchiolitis
- chest physiotherapy prescription
- bronchial obstruction confirmed by physician and respiratory physiotherapist
- children more than 1 year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy with SETChest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice) | Other | Chest physiotherapy with SET |
| Standard TreatmentStandard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices) | Other | Chest physiotherapy with SET, Standard treatment |
Primary outcome
Food ingestion
Time frame: 24 hours following intervention
Total Food ingestion within 24 hours after intervention measured by nurses or parents
6 secondary outcomes
Sleep quality
Time frame: 24 hours following intervention
Sleep quality
Time frame: 24 hours following intervention
Oxygen saturation
Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Respiratory rate
Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Heart Rate
Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Respiratory Distress
Time frame: Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 25349312Ralston 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.
- Background: PubMed 20927359Gajdos 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.
- Background: PubMed 19598273Gajdos 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.
- Derived from this study: PubMed 39334411Combret 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.
- Derived from this study: PubMed 37010196Roque-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Le Roux, MD principal investigator
Groupe Hospitalier du Havre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy with SET and Standard Treatment in people with Acute Viral Bronchiolitis, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food ingestion (time frame: 24 hours following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738501, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.