Cholestasis Clinical Trial
Official title:
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
NCT number | NCT00738101 |
Other study ID # | H-23365 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2008 |
Est. completion date | March 27, 2020 |
Verified date | May 2021 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 293 |
Est. completion date | March 27, 2020 |
Est. primary completion date | March 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility | Inclusion Criteria: - Be greater than 14 days old and less than 5 years old - Conjugated bilirubin greater than 2 mg/dL. - Be expected to require intravenous nutrition for at least an additional 28 days Exclusion Criteria: - Have a congenitally lethal condition (e.g. Trisomy 13). - Have clinically severe bleeding not able to be managed with routine measures. - Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis. - Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves. Home Use of Omegaven®: In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®. If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic. Outpatient Monitoring: After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Boston Children's Hospital |
United States,
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Chen WJ, Yeh SL, Huang PC. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clin Nutr. 1996 Feb;15(1):24-8. — View Citation
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Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6. Review. — View Citation
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Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248. — View Citation
Helms RA, Christensen ML, Mauer EC, Storm MC. Comparison of a pediatric versus standard amino acid formulation in preterm neonates requiring parenteral nutrition. J Pediatr. 1987 Mar;110(3):466-70. — View Citation
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Kubota A, Yonekura T, Hoki M, Oyanagi H, Kawahara H, Yagi M, Imura K, Iiboshi Y, Wasa K, Kamata S, Okada A. Total parenteral nutrition-associated intrahepatic cholestasis in infants: 25 years' experience. J Pediatr Surg. 2000 Jul;35(7):1049-51. — View Citation
Meehan JJ, Georgeson KE. Prevention of liver failure in parenteral nutrition-dependent children with short bowel syndrome. J Pediatr Surg. 1997 Mar;32(3):473-5. — View Citation
Moss RL, Das JB, Ansari G, Raffensperger JG. Hepatobiliary dysfunction during total parenteral nutrition is caused by infusate, not the route of administration. J Pediatr Surg. 1993 Mar;28(3):391-6; discussion 396-7. — View Citation
Moss RL, Haynes AL, Pastuszyn A, Glew RH. Methionine infusion reproduces liver injury of parenteral nutrition cholestasis. Pediatr Res. 1999 May;45(5 Pt 1):664-8. — View Citation
Mullick FG, Moran CA, Ishak KG. Total parenteral nutrition: a histopathologic analysis of the liver changes in 20 children. Mod Pathol. 1994 Feb;7(2):190-4. — View Citation
Nestel PJ. Effects of N-3 fatty acids on lipid metabolism. Annu Rev Nutr. 1990;10:149-67. Review. — View Citation
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study | Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin= 2 mg/dL prior to EOS (end of study). | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Primary | All Cause Mortality During the Study. | To describe proportion of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Primary | Growth Z-scores for Weight | The Z-score indicated the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean. A weight Z-score of = -2 indicates an underweight status, while a weight Z-score of = 2 indicates overweight or obese status. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis | To describe the number of infants who achieved resolution of cholestasis following initiation of fish oil emulsion. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | Number of Subjects With Platelet Count <100,000/µL | To describe the number of study subjects who experienced a platelet count below <100,000/µL anytime during the duration of the study. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | Number of Subjects With INR =1.4. | To describe the number of study subjects who experienced an INR =1.4 anytime during the duration of the study. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | Number of Study Subjects Who Experienced a Blood Stream Infection | To describe the number of study subjects who experienced a bloodstream infection during the duration of the study.
Bloodstream infection as defined by detection by the culture of bacteria or fungus from the blood. |
From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | Liver or Multi-visceral Transplant | To describe the number and percentage of infants who required liver or multi-visceral transplant. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | |
Secondary | All-cause Mortality up to Hospital Discharge | To describe number and percentage of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion. | Anytime from initiation of study to discharge from the hospital. |
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