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Published on: September 20, 2019
One-year Experience With Composite Intravenous Lipid Emulsion in Children on Home Parenteral Nutrition
Bram P Raphael1, Paul D Mitchell2, Alexandra Carey1
1Division of Gastroenterology, Hepatology and Nutrition.
Insights
Composite lipid emulsion (CLE) is safe for children on home parenteral nutrition (HPN). This study found CLE reduced glucose infusion rates and improved fatty acid profiles without adverse events in pediatric patients.
Area of Science:
- Pediatric Nutrition
- Intravenous Lipid Emulsions
- Gastroenterology
Background:
- Composite lipid emulsion (CLE) is FDA-approved for adults requiring parenteral nutrition.
- CLE offers theoretical advantages for pediatric patients on home parenteral nutrition (HPN) without cholestasis, including reduced phytosterol exposure and omega-3 supplementation.
Purpose of the Study:
- To evaluate the safety and efficacy of CLE in pediatric patients (<18 years) on HPN.
- To assess changes in anthropometrics, glucose infusion rates (GIRs), fatty acid profiles, and liver function tests over 12 months.
Main Methods:
- Prospective, single-center, open-label study.
- 57 pediatric patients on HPN received CLE (1-3 g/kg/day) for 12 months.
- Primary outcomes: changes in anthropometrics and GIRs; Secondary outcomes: fatty acid profiles and liver function.
Main Results:
- Mean GIRs decreased from 17 to 14 mg/kg/h at 4-6 months postbaseline.
- Stable growth parameters and a decline in mean arachidonic acid levels were observed.
- No significant adverse events were reported during the 12-month study period.
Conclusions:
- Composite lipid emulsion (CLE) is safe and well-tolerated in stable pediatric patients on home parenteral nutrition (HPN) for up to one year.
- Further research is warranted to determine long-term outcomes in this population.
Background:
Composite lipid emulsion (CLE) composed of soybean oil, medium-chain triglycerides, olive oil, and fish oil is approved in the US for parenterally fed adults. For stable children discharged on home parenteral nutrition (HPN) without cholestasis (direct bilirubin > 2.0 mg/dL), CLE has theoretical benefits over soybean-based intravenous lipid emulsion due to reduced phytosterol exposure with higher calorie support to permit reduced glucose infusion rates (GIRs), omega-3 supplementation, and supplemental α-tocopherol.
Methods:
In this prospective, single-center open-label research study, safety and efficacy outcomes were evaluated in patients on HPN younger than 18 years treated with CLE at 1 to 3 g · kg-1 · day-1 over 12 months. The primary outcome was change in anthropometrics and GIRs compared with baseline. Secondary outcomes were changes in fatty acid profiles and liver function and enzyme tests compared with baseline.
Results:
Fifty-seven subjects were treated with a median age of 7 years. The diagnosis was short bowel syndrome in 72%. Change in practice was associated with a decrease in mean GIRs from 17 to 14 mg · kg-1 · h-1 at 4 to 6 months postbaseline and beyond with a coincidental decline in mean arachidonic acid and stable growth parameters. No significant adverse events were noted.
Conclusions:
CLE was safe and well-tolerated in stable children on HPN at 1 year, but further studies are needed in this population to appreciate long-term outcomes.
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