Clinical trials: Cholestasis of Parenteral Nutrition
Cholestasis
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
- Trial name
- NCT02148146
- Testing
- Omegaven
- Where
- 2 sites in United States
- Sponsor
- University of California, San Diego
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
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
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
Cholestasis, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of 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
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
This study will demonstrate Short-, mid-, and long-term 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…
- Conditions
- Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency, Neurocognitive Deficit, Malnutrition
- Trial name
- NCT04807478
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Sponsor
- Fresenius Kabi
Cholestasis
Compassionate Use of Omegaven
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously.
- Trial name
- NCT02778698
- Testing
- Omegaven
- Sponsor
- Geisinger Clinic
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
Short Bowel Syndrome
Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off Total Parenteral…
- Trial name
- NCT01891279
- Testing
- elemental formula Elecare®, partially hydrolyzed formula
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center, Houston
Cholestasis, Jaundice, Obstructive
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.
- Trial name
- NCT02721277
- Testing
- SMOFlipid
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Florida
Cholestasis
A Trial of Taurine Supplementation in Parenteral Nutrition 1
The purpose of this study is to investigate whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease, a common…
- Trial name
- NCT00135044
- Testing
- intravenous taurine in nutritional supplement
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- London North West Healthcare NHS Trust
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, Liver Disease
Compassionate Use of Omegaven IV Fat Emulsion
This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver…
- Trial name
- NCT02477345
- Testing
- Omegaven IV
- Where
- United States
- Sponsor
- Northwell Health
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
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
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 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
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