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

ISRCTN	ISRCTN47796385
DOI	https://doi.org/10.1186/ISRCTN47796385
Protocol serial number	N0515122182
Sponsor	Department of Health (UK)
Funder	North West London Hospitals NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 12/12/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kiran Nistala
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised open controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison of oral and nasogastric (n/g) rehydration in childhood gastroenteritis
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The main outcome measure is percentage weight gain at 4 h from the onset of rehydration
Key secondary outcome measure(s)	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
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	5 Years
Sex	Not Specified
Target sample size at registration	88
Key inclusion criteria	Patients aged 3 months to 5 years.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/2002
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

North West London Hospitals NHS Trust

Harrow
HA1 3UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan