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Trial registered on ANZCTR


Registration number
ACTRN12608000098336
Ethics application status
Not yet submitted
Date submitted
20/02/2008
Date registered
21/02/2008
Date last updated
21/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of oral and intravenous saline to replace ileostomy fluid losses in infants (pilot study)
Scientific title
A comparison of oral and intravenous saline to replace ileostomy fluid losses in infants (pilot study)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ileostomy 2852 0
Neonatal Intensive care 2853 0
Condition category
Condition code
Other 2985 2985 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of intravenous 0.9% saline (and 10 mmol potassium chloride per 500 ml) versus oral gastrolyte to replace high-output ileostomy losses in newborn infants whilst in intensive care. Both treatment arms will be for two weeks. Both interventions will involve replacement of ileostomy fluid losses >20 mmol/kg/d volume for volume.
Intervention code [1] 2582 0
Treatment: Drugs
Comparator / control treatment
This a pilot cross-over trial and intravenous saline (and KCL) will be the 'control treatment' as it represents standard care.
Control group
Active

Outcomes
Primary outcome [1] 3865 0
weight gain after two weeks of treatment
Timepoint [1] 3865 0
Weight every three days during the two weeks using each treatment arm
Secondary outcome [1] 6506 0
Weekly Urinary and ileostomy fluid sodium values (mmol).
Timepoint [1] 6506 0
weekly during the two weeks using each treatment arm
Secondary outcome [2] 6507 0
Treatment failure (Ileostomy losses >40 mL/kg/d for three consecutive days or four days within one calendar week and/or weight loss >10% of weight at study commencement over 3 days) and complications, such as central line sepsis
Timepoint [2] 6507 0
Monitoring for complications will occur on a daily basis through out the complete duration of the study.

Eligibility
Key inclusion criteria
Infants with an ileostomy will be considered eligible for inclusion if:
• They are stable on full enteral feeds, or within 48 hours of ceasing total parenteral nutrition (TPN).
• They require replacement fluid for ileostomy losses between 20 – 40 mL/kg/day.
• They are already receiving additional salt supplementation as part of clinical care.
• Signed, informed parental consent can be obtained prior to enrollment.
• The treating Consultant Neonatologist gives permission for enrollment.
All gestational age, birth weight, weight at enrollment, and surgical diagnoses will be eligible.
Minimum age
14 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with an ileostomy will be excluded if they have:
• Ileostomy loss >40ml/kg/day.
• A known chronic salt losing condition, such as renal failure or congenital adrenal hyperplasia.
• Requirement of mechanical ventilation support via an endotracheal tube.
• Haemodynamic instability despite maximal inotropic and fluid support.

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)
eligible infants will be identified by ward nursing staff and study investigators informed. If informed, written parental consent can be obtained they infant will be enrolled. At time of enrollment, infants will be allocated an treatment arm using a block randomization process. After two weeks of the first treatment the infant will be switched to two weeks of the alternative treatment. this is a PILOT STUDY
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation process. Randomisation will be performed by the Institutions Center of Epidemiology and Biostatistics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 582 0
3052

Funding & Sponsors
Funding source category [1] 3108 0
Self funded/Unfunded
Name [1] 3108 0
Country [1] 3108 0
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Rd
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 2796 0
None
Name [1] 2796 0
Address [1] 2796 0
Country [1] 2796 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5082 0
Ethics and Research Department
Ethics committee address [1] 5082 0
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 5082 0
Australia
Date submitted for ethics approval [1] 5082 0
20/01/2008
Approval date [1] 5082 0
Ethics approval number [1] 5082 0
28007

Summary
Brief summary
In infants with gastrointestinal complications, constructing an ileostomy is a common temporising
surgical intervention whilst waiting for future definitive surgery. An ileostomy is a surgically created
opening into the ileum (the final part of the small intestine) which connects the healthy end of the
ileum to an artifical bag on the surface of the skin; allowing the distal and diseased bowel to be
bypassed and heal. Intestinal waste passes out of the ileostomy, bypassing the colon. Intestinal
waste which has bypassed the colon usually has a higher content of water and electrolytes because
the small intestine does not conserve electrolytes, in particular sodium as well as the colon.
It is known that infants with high ileostomy fluid losses are at risk of dehydration, sodium deficit
and failure to thrive. To prevent this, clinicians at the Royal Children's Hospital (RCH) Neonatal Unit
(NNU) have traditionally replaced ileostomy fluid losses with intravenous saline when those losses
are above 20ml/kg/day. This method requires recurrent insertion of intravenous cannulae, or
insertion of central venous lines because the median duration between fashioning and closing an
ileostomy is 44 days (Range 16-107 days). Central lines are important risk factors for sepsis in
infants. Moreover, some infants have very difficult intravenous access. Therefore in these situations,
clinicians at RCH NNU have been replacing high volume ileostomy fluid losses with oral rehydration
solution.
The aim of this pilot study is to determine sample size calculations, data variability and feasibility
for a future study with the specific aim to determine whether oral rehydration solution replacement
is as effective as intravenous saline for replacement of ileostomy fluid losses in infants.
In this study consented infants with ileostomy fluid losses of 20-40ml/kg/day who are tolerating full
enteral feeds and additional salt supplementation will be allocated to receive both intravenous saline
and oral rehydration solution for two weeks each. The order of which will be randomly assigned.
They will receive each type of rehydration fluid for 14 days; a total of 28 days. Irrespective of the
method of fluid replacement, the ileal fluid volume will be replaced over the following 24 hours if
over 20ml/kg/day.
During the study, information including third daily weight; weekly urine sodium, ileostomy sodium
and sodium supplementation dose; daily total fluid balance (total fluid input and output), ileostomy
losses and replacement, and any complications that may occur will be recorded on a standardised
data sheet. No additional blood tests are required, therefore discomfort should be no greater than
currently associated with being an inpatient in the NNU.
Descriptive statistics will be generated for all outcome measures to determine population variability
and sample size for a larger study.
Trial website
N/A
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 28388 0
Address 28388 0
Country 28388 0
Phone 28388 0
Fax 28388 0
Email 28388 0
Contact person for public queries
Name 11545 0
Dr David Tingay
Address 11545 0
Department of Neonatology
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 11545 0
Australia
Phone 11545 0
03 93455008
Fax 11545 0
03 93455067
Email 11545 0
[email protected]
Contact person for scientific queries
Name 2473 0
Dr David Tingay
Address 2473 0
Department of Neonatology
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 2473 0
Australia
Phone 2473 0
03 93455008
Fax 2473 0
03 93455067
Email 2473 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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