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RecruitingNCT063047271TreSBCDUpdated Mar 12, 2024

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

An observational study in Bronchiolitis, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 8 Weeks to 1 Year. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
8 Weeks to 1 Year
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiolitis

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Keywords

  • infant
  • bronchiolitis
  • enteral feeding
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 79 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Weeks to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children being treated according to our Short-Term Enteral Nutrition Protocol

Exclusion criteria

Exclusion Criteria:

  • Parents refusal
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: clinical data review

Interventions

  • Otherclinical data review

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

06

What researchers measure

Primary outcomes

  1. Feasibility of the short enteral feeding protocol

    yes/no Protocol outcome (return home or hospitalization, new short-term consultation)

    Time frame: From day1 of protocol inclusion

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06304727
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Nov 21, 2022
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Dominique PLOIN, MD
Contact
dominique.ploin@chu-lyon.fr
0427855642 ext. +33
Côme HORVAT, MD
Contact
come.horvat@chu-lyon.fr
047855634 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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