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Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

NCT06274788

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutrition+1 more

Fresenius Kabi40 participantsStarted Dec 2024

Fountain Valley, California, United States • Los Angeles, California, United States • Chicago, Illinois, United States +7 more locations

UNKNOWNPhase 2/3

Minimization of IntraLipid Versus Omegaven

NCT01247012

Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

CholestasisParenteral Nutrition Associated Liver Disease (PNALD)

Children's & Women's Health Centre of British Columbia40 participantsStarted Dec 2010

Vancouver, British Columbia, Canada

Data from ClinicalTrials.govTerms

Showing 1-2 of 2 trials

RECRUITING

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

NCT06274788

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutrition+1 more

Fresenius Kabi40 participantsStarted Dec 2024

Fountain Valley, California, United States • Los Angeles, California, United States • Chicago, Illinois, United States +7 more locations

UNKNOWNPhase 2/3

Minimization of IntraLipid Versus Omegaven

NCT01247012

Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

CholestasisParenteral Nutrition Associated Liver Disease (PNALD)

Children's & Women's Health Centre of British Columbia40 participantsStarted Dec 2010

Vancouver, British Columbia, Canada

Data from ClinicalTrials.govTerms

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Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Minimization of IntraLipid Versus Omegaven

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Minimization of IntraLipid Versus Omegaven