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

Dehydration Clinical Trial

— GEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555200
• Other study ID #: 29BRC19.0130
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: October 2, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2, 2019
• Est. primary completion date: October 1, 2019
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Dehydration
• Gastroenteritis

Locations

Country	Name	City	State
France	CHRU de Brest (urgences pédiatriques)	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of nasogastric tube after changing gastroenteritis rehydration protocol	assessed by the number of NG tube and IV in each group	4 months
Secondary	Hospital lenght of stay between each group	evaluate by administrative data of each case (arrival time and departure time)	4 months
Secondary	Number of Participants With Treatment-Related Adverse Events for each method	Serious sides effect were death and epilptic seizure. Mild sides effects were multiple (IV or NG ripped out, vomiting, failure...).	4 months