None listed
Conditions
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.
Interventions
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.
Sponsors
Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
14 Days to 6 Months
Healthy volunteers
No
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.
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.
Outcome results
None listed