- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06304727
Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment (1TreSBCD)
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dominique PLOIN, MD
- Phone Number: +33 0427855642
- Email: dominique.ploin@chu-lyon.fr
Study Contact Backup
- Name: Côme HORVAT, MD
- Phone Number: +33 047855634
- Email: come.horvat@chu-lyon.fr
Study Locations
-
-
-
Bron, France
- Recruiting
- Hôpital Femme Mère Enfant
-
Contact:
- Dominique PLOIN, MD
- Phone Number: +33 0427855642
- Email: dominique.ploin@chu-lyon.fr
-
Contact:
- Côme HORVAT, MD
- Phone Number: +33 0427855634
- Email: come.horvat@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children being treated according to our Short-Term Enteral Nutrition Protocol
Exclusion Criteria:
- Parents refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Medical records review to gather and analyze demographic, clinical, care and virological data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
From day1 of protocol inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-5064
- Easydore (Other Identifier: 69HCL23_0736)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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