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Trial registered on ANZCTR


Registration number
ACTRN12610000737033
Ethics application status
Approved
Date submitted
2/09/2010
Date registered
3/09/2010
Date last updated
11/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial of 4-hour versus 24-hour nasogastric rehydration in children with acute gastroenteritis and moderate dehydration
Scientific title
Randomized controlled trial of the clinical efficacy and safety of 4-hour nasogastric rehydration in the Emergency Department versus 24-hour nasogastric rehydration in hospital in children with acute viral gastroenteritis and moderate dehydration
Secondary ID [1] 252626 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute viral gastroenteritis with moderate dehydration 258124 0
Condition category
Condition code
Oral and Gastrointestinal 258298 258298 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasogastric rehdydration is a standard treatment of mild to moderate dehydration in patients with gastroenteritis. A nasogastric tube is inserted through the nose into the stomach and oral rehydration fluid slowly infused, as clinically indicated.

Patients will be randomised to receive one of two nasogastric rehydration regimens:
1 - Rapid nasogastric rehydration (RNR) over 4 hours (100 ml/kg total); or
2 - Slow nasogastric rehydration (SNR) over 24 hours (replacement of 5-7% body weight over 24 hours)
Intervention code [1] 257139 0
Treatment: Drugs
Comparator / control treatment
Patients will be treated with standard or rapid nasogastric rehydration, as randomised.

Standard nasogastric rehydration (SNR) involves replacement of the estimated fluid deficit (5-7% body weight) and maintenance requirements via a nasogastric tube over 24 hours in hospital.

Rapid nasogastric rehydration (SNR) involves replacement of 100mls/kg of oral rehydration solution via a nasogastric tube over 4 hours in the Emergency Department.
Control group
Dose comparison

Outcomes
Primary outcome [1] 259147 0
Clinical treatment failure of rehydration schedules defined as >2% body weight from time of admission after randomisation
Main outcome measures: body weight
Timepoint [1] 259147 0
Admission to Emergency Department (enrolment and randomisation)

Reviews and measurement of body weight at 4-6 hours, 24 hours and 7 days from time of randomisation
Secondary outcome [1] 265474 0
Secondary treatment failure is defined as:
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)
2 - need for insertion of intravenous (IV) cannula for IV rehydration for either rehydration schedule at any time point after randomisation
Timepoint [1] 265474 0
Admission to Emergency Department (enrolment and randomisation)

Reviews at 4-6 hours, 24 hours and 7 days from time of randomisation

Eligibility
Key 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)
Minimum age
6 Months
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3212 0
3052
Recruitment postcode(s) [2] 3213 0
3021

Funding & Sponsors
Funding source category [1] 257589 0
Government body
Name [1] 257589 0
Department of Human Services
Address [1] 257589 0
50 Lonsdale Street
Melbourne VIC 3000
Country [1] 257589 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital Melbourne
Address
50 Flemington Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 256815 0
Hospital
Name [1] 256815 0
Sunshine Hospital
Address [1] 256815 0
175 Furlong Road
St. Albans VIC 3021
Country [1] 256815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259612 0
Royal Children's Hospital Melbourne
Ethics committee address [1] 259612 0
50 Flemington Road
Parkville VIC 3052
Ethics committee country [1] 259612 0
Australia
Date submitted for ethics approval [1] 259612 0
Approval date [1] 259612 0
11/05/2001
Ethics approval number [1] 259612 0
20128

Summary
Brief summary
Objectives: To compare the efficacy of two nasogastric rehydration regimens in children with acute viral gastroenteritis.

Patients and methods: Children aged 6-72 months with acute viral gastroenteritis and moderate dehydration were recruited from Emergency Departments (ED) at two metropolitan pediatric teaching hospitals. After a clinical assessment of the degree of dehydration, patients were randomized to receive either standard nasogastric rehydration (SNR) over 24 hours in the
hospital ward, or rapid nasogastric rehydration (RNR) over 4 hours in the ED. Primary treatment failure was defined as weight loss of >2%, compared to the admission weight. Secondary treatment failure was defined as the need for (re-)admission to hospital, insertion of an intravenous line for rehydration or inability to tolerate nasogastric rehydration.

Results: Of 9331 children with acute gastroenteritis screened, 228 children were recruited and randomized (RNR 119 [52.2%], SNR 109 [47.8%]). Baseline characteristics for both groups were similar. All patients made a full recovery without severe adverse events. Primary failure rate at 24 hrs was similar for RNR 12.6% (95% confidence interval [CI]; 6.6–18.6) and SNR 8.3% (95%CI; 3.1–13.5); p=0.12. Secondary treatment failure was more common in SNR patients 44% (95% CI; 34.6–53.4) vs RNR 31.1% (95%CI; 22.0–38.6); p=0.03. Discharge from the ED after RNR failed in 28 (23.5%) patients, and 9 (7.5%) were re-admitted within 24 hrs.

Conclusion: Primary treatment failure and clinical outcomes were similar for RNR and SNR. While RNR generally reduced need for hospitalization, discharge home from the ED failed in about one quarter of patients.
Trial website
Trial related presentations / publications
Powell CV, Priestley SJ, Young S and Heine RG. Randomized clinical trial of rapid versus 24-hour rehydration for children with acute gastroenteritis. Pediatrics. 2011;128:e771-8
Public notes

Contacts
Principal investigator
Name 31601 0
Address 31601 0
Country 31601 0
Phone 31601 0
Fax 31601 0
Email 31601 0
Contact person for public queries
Name 14848 0
Dr Ralf Heine MD FRACP
Address 14848 0
Dept of Gastroenterology & Clinical Nutrition
Royal Children’s Hospital
Parkville VIC 3052
Country 14848 0
Australia
Phone 14848 0
+61 3 9345 5060
Fax 14848 0
+61 3 9345 6240
Email 14848 0
ralf.heine@rch.org.au
Contact person for scientific queries
Name 5776 0
Dr Ralf Heine MD FRACP
Address 5776 0
Dept of Gastroenterology & Clinical Nutrition
Royal Children’s Hospital
Parkville VIC 3052
Country 5776 0
Australia
Phone 5776 0
+61 3 9345 5060
Fax 5776 0
+61 3 9345 6240
Email 5776 0
ralf.heine@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary