NCT04555200

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

July 6, 2020

Last Update Submit

September 17, 2020

Conditions

Acute GastroenteritisDehydration

Keywords

nasogastric tubeEmergency medicinePediatric medicine

Outcome Measures

Primary Outcomes (1)

  • Number of nasogastric tube after changing gastroenteritis rehydration protocol

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

    4 months

Secondary Outcomes (2)

  • Hospital lenght of stay between each group

    4 months

  • Number of Participants With Treatment-Related Adverse Events for each method

    4 months

Eligibility Criteria

Age1 Day - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • acute gastroenteritis on return from tropical countries
  • child with endocrine system diseases requiring parenteral rehydration
  • history of chronic pathology requiring enteral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest (urgences pédiatriques)

Brest, France

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nadege Delaperriere, Doctor

    CHRU Brest

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 6, 2020

First Posted

September 18, 2020

Study Start

June 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 2, 2019

Last Updated

September 18, 2020

Record last verified: 2019-09

Locations

FR(1)