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Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year

Trial Profile

Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year

Not yet recruiting
Phase of Trial: Phase IV

Latest Information Update: 13 Feb 2019

At a glance

  • Drugs Soya oil emulsion/medium-chain triglyceride/olive oil/fish oil (Primary) ; Soya oil emulsion
  • Indications Malnutrition
  • Focus Adverse reactions; Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Sponsors Fresenius Kabi
  • Most Recent Events

    • 04 Feb 2019 Planned initiation date changed from 1 Nov 2018 to 1 Apr 2019.
    • 31 Aug 2018 Planned initiation date changed from 1 Jun 2018 to 1 Nov 2018.
    • 27 Jun 2018 New trial record
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