Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kiran Nistala

ORCID ID

Contact details

Paediatric Ambulatory Care Unit
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515122182

Study information

Scientific title

Comparison of oral and nasogastric (n/g) rehydration in childhood gastroenteritis

Acronym

Study hypothesis

Hypothesis: The World Health Organisation has published guidelines for use of oral rehydration solution (ORS) in childhood gastroenteritis. The solution can be administered by mouth or via nasogastric (n/g) tube. We hypothesise that oral administration, which is successful in the developing world, will not be effective in the UK. The comparison of the two methods has not been tested in a developed world setting.
Value: Determine the most effective and best tolerated method of rehydration which may reduce hospital admissions.

Ethics approval

Not provided at time of registration

Study design

Randomised open controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Digestive System: Gastroenteritis

Intervention

Following an initial 30 min assessment all children who had not successfully taken and tolerated 10 ml/kg oral rehydration solution (ORS) would be approached for trial entry. Parents will be consented by research nurse/PACU registrar. Children would have a baseline set of observations, and clinical assessment of dehydration (according to American Academy of Paediatrics protocol). Standard history taking and examination will be carried out.

Randomisation to oral or n/g group done by pre-prepared packs with sealed, opaque envelopes.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome measure is percentage weight gain at 4 h from the onset of rehydration

Secondary outcome measures

1. Failure of rehydration, defined as follows:
1.1 n/g group: failure to pass n/g after three attempts or vomiting of n/g tube on more than one occasion OR
1.2 Oral group: patient failed to take 80% of expected volume at 2 h or >three vomits from hour
2. Parental satisfaction questionnaires

Overall trial start date

01/12/2002

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 3 months to 5 years.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

88 patients in total, 44 in each group

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2002

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North West London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes