Continuous Enteral Rehydration by Nasogastric Tube With O... | NCT04555200

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

NCT04555200

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Acute Gastroenteritis
Dehydration

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Oct 1, 2019Actual

Completion Date

Oct 2, 2019Actual

First Submitted Date

Jul 6, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2020

Last Update Posted Date

Sep 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hospital lenght of stay between each group	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

15 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nadege Delaperriere, Doctor	CHRU BREST	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest (urgences pédiatriques)		Brest			France

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided