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NCT06304727 Clinical Trial

Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment

Bronchiolitis Clinical Trial

— 1TreSBCD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06304727
Other study ID # 23-5064
Secondary ID Easydore
Status Recruiting
Phase
First received
Last updated
Start date November 21, 2022
Est. completion date June 30, 2024

Study information
Verified date January 2024
Source Hospices Civils de Lyon
Contact Dominique PLOIN, MD
Phone 0427855642
Email dominique.ploin@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 30, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Weeks to 1 Year
Eligibility Inclusion Criteria: - Children being treated according to our Short-Term Enteral Nutrition Protocol Exclusion Criteria: - Parents refusal

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• clinical data review
Medical records review to gather and analyze demographic, clinical, care and virological data

Locations
Country Name City State
France Hopital Femme Mere Enfant Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of the short enteral feeding protocol yes/no Protocol outcome (return home or hospitalization, new short-term consultation) From day1 of protocol inclusion
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