Randomized controlled trial of 4-hour versus 24-hour nasogastric rehydration in children with acute gastroenteritis and moderate dehydratio

Not Applicable

Completed

• Conditions: Acute viral gastroenteritis with moderate dehydration; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12610000737033
• Lead Sponsor: Royal Children's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

Children with acute gastroenteritis and moderate dehydration presenting to the Emergency Department at 2 metropolitan paediatric teaching hospitals

Acute diarrhoea (non-bloody)

Moderate dehydration defined as 3 clinical signs (based on Gorelick study criteria)

Exclusion Criteria

1 - Bloody diarrhoea,
2 - Severe dehydration (dehydration score > 7)
3 - Mild dehydration (dehydration score < 3)
4 - Unable to obtain written informed consent,
5 - Patient living outside area covered by hospital-in-the-home (part of follow-up at 24 hrs and 7 days)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical treatment failure of rehydration schedules defined as >2% body weight from time of admission after randomisation<br>Main outcome measures: body weight[Admission to Emergency Department (enrolment and randomisation)<br><br>Reviews and measurement of body weight at 4-6 hours, 24 hours and 7 days from time of randomisation]

Secondary Outcome Measures

Name	Time	Method
Secondary treatment failure is defined as:<br>1 - need for hospital admission at any time point after rapid rehydration (4 hrs), or re-admission after discharge from hospital for standard rehydration (24 hrs) <br>2 - need for insertion of intravenous (IV) cannula for IV rehydration for either rehydration schedule at any time point after randomisation[Admission to Emergency Department (enrolment and randomisation)<br><br>Reviews at 4-6 hours, 24 hours and 7 days from time of randomisation]