Bronchiolitis1TreSBCDNCT06304727
Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment
An observational study of Bronchiolitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of… Read more about this study
- Who is it for?
- Ages 8 weeks to 1 year
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- clinical data review
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2022to 30 Jun 2024
- Phase
- Observational
- 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 8 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Inclusion of all infants under one year old presenting a bronchiolitis with exclusive nutritional impairment and treated in the emergency room of the Hôpital Femme Mère Enfant according to the Protocole de prise en charge de la bronchiolite avec forme digestive prédominante à l'accueil des urgences de l'HFME (Protocol for the management of bronchiolitis with a predominantly digestive form at the HFME emergency department)- ZSBCD. This population will constitute a restrospective cohort in a pediatric tertiary care hospital during the 2022-2023 bronchiolitis season.
Who may be able to join
- Children being treated according to our Short-Term Enteral Nutrition Protocol
Who cannot join
- Parents refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Femme Mere Enfant
Bron
Dominique PLOIN, MD, 0427855642 ext. +33, dominique.ploin@chu-lyon.fr
Côme HORVAT, MD, 0427855634 ext. +33, come.horvat@chu-lyon.fr
About this study
Official title: Evaluation of Short Enteral Nutrition and Monitoring in the Emergency Room for Infants Under 1 Year of Age With Bronchiolitis With Main Nutritional Impairment
The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.
A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.
A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.
- Conditions
- Bronchiolitis
- Being tested
- clinical data review
- Keywords
- infant, bronchiolitis, enteral feeding
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical data reviewOther
Medical records review to gather and analyze demographic, clinical, care and virological data
| Study group | Role | What they receive |
|---|---|---|
| enteral feeding group | Infants < 1 year old with bronchiolitis and exclusive nutritional impairment who underwent short-term enteral feeding and monitoring in the emergency room according to the 2022-2024 seasons protocol Receives: Other: clinical data review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the short enteral feeding protocol
yes/no Protocol outcome (return home or hospitalization, new short-term consultation)
Measured: From day1 of protocol inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start21 Nov 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304727
- Sponsor's protocol ID
- 23-5064
- Other IDs
- Easydore
- Acronym
- 1TreSBCD
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short Enteral Nutrition and Monitoring in the Emergency Room for Infants Under 1 Year of Age With Bronchiolitis With Main Nutritional Impairment
- ClinicalTrials.gov ID
- NCT06304727
- Acronym / sponsor ID
- 1TreSBCD / 23-5064
- Conditions
- Bronchiolitis
- Keywords
- infant, bronchiolitis, enteral feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (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 winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.
A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.
A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enteral feeding group | – | Other: clinical data reviewInfants < 1 year old with bronchiolitis and exclusive nutritional impairment who underwent short-term enteral feeding and monitoring in the emergency room according to the 2022-2024 seasons protocol |
Who may qualify
- Ages
- 8 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Inclusion of all infants under one year old presenting a bronchiolitis with exclusive nutritional impairment and treated in the emergency room of the Hôpital Femme Mère Enfant according to the Protocole de prise en charge de la bronchiolite avec forme digestive prédominante à l'accueil des urgences de l'HFME (Protocol for the management of bronchiolitis with a predominantly digestive form at the HFME emergency department)- ZSBCD. This population will constitute a restrospective cohort in a pediatric tertiary care hospital during the 2022-2023 bronchiolitis season.
Key inclusion criteria (1 listed)
- Children being treated according to our Short-Term Enteral Nutrition Protocol
Key exclusion criteria (1 listed)
- Parents refusal
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 |
|---|---|---|
| clinical data reviewMedical records review to gather and analyze demographic, clinical, care and virological data | Other | enteral feeding group |
Primary outcome
Feasibility of the short enteral feeding protocol
Time frame: From day1 of protocol inclusion
yes/no Protocol outcome (return home or hospitalization, new short-term consultation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Hospices Civils de Lyon 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique PLOIN, MD (0427855642 ext. +33, dominique.ploin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the short enteral feeding protocol (time frame: From day1 of protocol inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.