Clinical trials: Parenteral Nutrition Associated Cholestasis
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by…
- Trial name
- NCT00826020
- Testing
- Omegaven™
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Nebraska
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
Minimization of IntraLipid Versus Omegaven
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…
- Trial name
- MILOve (NCT01247012)
- Testing
- Omegaven, Lipid minimization
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Children's & Women's Health Centre of British Columbia
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Cholestasis of Parenteral Nutrition
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may…
- Trial name
- NCT01861834
- Testing
- Omegaven 10%
- Where
- 2 sites in United States
- Sponsor
- Georgetown University
Short Bowel Syndrome, Cholestasis
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.
- Trial name
- NCT01739517
- Testing
- Omegaven Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Amarnath, Rathna, M.D.
Liver Disease
Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease
Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition.
- Trial name
- NCT02452177
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shengxian Fan
Cholestasis
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
- Trial name
- URSONEONAT (NCT00846963)
- Testing
- Ursodiol
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Ibrahim Mohamed
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated…
- Trial name
- NCT01412359
- Testing
- Omegaven®
- Where
- United States
- Sponsor
- Jeffrey Rudolph
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Parenteral Nutrition Associated Cholestasis
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
- Trial name
- NCT01555957
- Testing
- intravenous lipid
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Rochester
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either…
- Trial name
- NCT01323907
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Sivan Kinberg
Total Parenteral Nutrition-Induced Cholestasis
Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated…
- Trial name
- NCT02328768
- Testing
- Omegaven
- Where
- United States
- Sponsor
- University of Nebraska
Cholestasis
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the…
- Trial name
- NCT00004410
- Testing
- tauroursodeoxycholic acid
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Short Bowel Syndrome
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS.
- Trial name
- NCT01974336
- Testing
- ursodeoxycholic acid
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jinling Hospital, China
Total Parenteral Nutrition-induced Cholestasis
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
- Trial name
- NCT02929303
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Intrahepatic, Cholestasis
Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions
Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN).
- Trial name
- NCT02633384
- Testing
- SMOFlipid, Lipofundin
- Volunteers
- 52 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Total Parenteral Nutrition-induced Cholestasis
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT02534077
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Pediatrix