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GEA: Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04555200
Collaborator
(none)
88
Enrollment
1
Location
16
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The main purpose was to assess the proportion of children rehydrated by nasogastric tube(NG) after protocol change. Secondary outcomes were to assess hospital length of stay and sides effects.

    It is a retro and prospective study. The first phase took place from June to September 2018 and the second from June to September 2019. Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    88 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    Oct 1, 2019
    Actual Study Completion Date :
    Oct 2, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Number of nasogastric tube after changing gastroenteritis rehydration protocol [4 months]

      assessed by the number of NG tube and IV in each group

    Secondary Outcome Measures

    1. Hospital lenght of stay between each group [4 months]

      evaluate by administrative data of each case (arrival time and departure time)

    2. Number of Participants With Treatment-Related Adverse Events for each method [4 months]

      Serious sides effect were death and epilptic seizure. Mild sides effects were multiple (IV or NG ripped out, vomiting, failure...).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 15 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included

    Exclusion Criteria:

    • acute gastroenteritis on return from tropical countries

    • child with endocrine system diseases requiring parenteral rehydration

    • history of chronic pathology requiring enteral feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest (urgences pédiatriques) Brest France

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: Nadege Delaperriere, Doctor, CHRU Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04555200
    Other Study ID Numbers:
    • 29BRC19.0130
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    Sep 18, 2020
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    nasogastric tube
    Emergency medicine
    Pediatric medicine
    Additional relevant MeSH terms:
    Gastroenteritis
    Dehydration

    Study Results

    No Results Posted as of Sep 18, 2020