NCT06304727

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

January 18, 2024

Last Update Submit

March 8, 2024

Conditions

Keywords

infantbronchiolitisenteral feeding

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the short enteral feeding protocol

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

    From day1 of protocol inclusion

Study Arms (1)

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

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

enteral feeding group

Eligibility Criteria

Age8 Weeks - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Parents refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mere Enfant

Bron, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Central Study Contacts

Dominique PLOIN, MD

CONTACT

Côme HORVAT, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

March 12, 2024

Study Start

November 21, 2022

Primary Completion

June 1, 2024

Study Completion

June 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-01

Locations