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

September 17, 2020 updated by: University Hospital, Brest

Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHRU de Brest (urgences pédiatriques)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 15 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any child from 0 to 15 years presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of nasogastric tube after changing gastroenteritis rehydration protocol
Time Frame: 4 months
assessed by the number of NG tube and IV in each group
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital lenght of stay between each group
Time Frame: 4 months
evaluate by administrative data of each case (arrival time and departure time)
4 months
Number of Participants With Treatment-Related Adverse Events for each method
Time Frame: 4 months
Serious sides effect were death and epilptic seizure. Mild sides effects were multiple (IV or NG ripped out, vomiting, failure...).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Nadege Delaperriere, Doctor, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

October 2, 2019

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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