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ISRCTN
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ISRCTN47796385
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ClinicalTrials.gov identifier
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Public title
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Comparison of oral and nasogastric (n/g) rehydration in childhood gastroenteritis
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0515122182
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised open controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive System: Gastroenteritis
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Participants - inclusion criteria
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Patients aged 3 months to 5 years.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/2002
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Anticipated end date
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31/03/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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88 patients in total, 44 in each group
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Interventions
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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.
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Primary outcome measure(s)
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The main outcome measure is percentage weight gain at 4 h from the onset of rehydration
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Secondary outcome measure(s)
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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
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Sources of funding
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North West London Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Kiran
Nistala
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Address
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Paediatric Ambulatory Care Unit
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
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City/town
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Harrow
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Zip/Postcode
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HA1 3UJ
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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08/11/2011
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Date ISRCTN assigned
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12/09/2003
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