Clinical trials: Cholestasis of Parenteral Nutrition
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
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Cholestasis of Parenteral Nutrition
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related…
- Trial name
- UDACPPNAC (NCT05043194)
- Testing
- Ursodeoxycholic Acid 250 Mg Oral Capsule
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Wei Liu
Cholestasis in Newborn
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late…
- Trial name
- NCT06366880
- Testing
- Parenteral nutrition cycling
- Where
- Mexico
- Volunteers
- 66 people
- Sponsor
- Hospital Pediátrico de Sinaloa
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
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
Cholestasis of Parenteral Nutrition
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure.
- Trial name
- NCT03387579
- Testing
- Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Indiana University
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.
- Trial name
- NCT02780193
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Rush University Medical Center
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
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
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
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
Cholestasis
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's…
- Trial name
- NCT01173159
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cholestasis, Growth Failure
SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day.
- Trial name
- SMOF (NCT02412566)
- Testing
- SMOFlipid
- Where
- United States
- Sponsor
- Baylor College of Medicine
Cholestasis, Parenteral Nutrition
Cholestasis Prevention: Efficacy of IV Fish Oil
Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury…
- Trial name
- NCT00512629
- Testing
- Omegaven, Intralipid
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston Children's Hospital
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
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.
Cholestasis in Newborn
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN.
- Trial name
- NCT02692326
- Testing
- Cyclic parenteral nutrition
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
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
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Cholestasis, Short Bowel Syndrome
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).
- Trial name
- Omegaven (NCT01297933)
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia