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To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral fish oil | Experimental | Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally. |
|
| UDCA (ursodeoxycholic acid) | Active Comparator | Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally |
|
| Placebo | Placebo Comparator | Infant will receive placebo in two daily doses given enterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral fish oil | Drug |
|
| |
| Ursodeoxycholic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Direct Bilirubin | Direct bilirubin less than 1 mg/dL considered resolution of cholestasis | Evaluated every 7 days up to 180 days |
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Inclusion Criteria:
Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Blanco, M.D. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9437702 | Background | Kelly DA. Liver complications of pediatric parenteral nutrition--epidemiology. Nutrition. 1998 Jan;14(1):153-7. doi: 10.1016/s0899-9007(97)00232-3. | |
| 17344923 | Background | Christensen RD, Henry E, Wiedmeier SE, Burnett J, Lambert DK. Identifying patients, on the first day of life, at high-risk of developing parenteral nutrition-associated liver disease. J Perinatol. 2007 May;27(5):284-90. doi: 10.1038/sj.jp.7211686. Epub 2007 Mar 8. |
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| Drug |
|
|
| Placebo | Drug |
|
|
| 17208555 | Background | Nathan JD, Rudolph JA, Kocoshis SA, Alonso MH, Ryckman FC, Tiao GM. Isolated liver and multivisceral transplantation for total parenteral nutrition-related end-stage liver disease. J Pediatr Surg. 2007 Jan;42(1):143-7. doi: 10.1016/j.jpedsurg.2006.09.049. |
| 11071594 | Background | Colomb V, Jobert-Giraud A, Lacaille F, Goulet O, Fournet JC, Ricour C. Role of lipid emulsions in cholestasis associated with long-term parenteral nutrition in children. JPEN J Parenter Enteral Nutr. 2000 Nov-Dec;24(6):345-50. doi: 10.1177/0148607100024006345. |
| 16150347 | Background | Javid PJ, Greene AK, Garza J, Gura K, Alwayn IP, Voss S, Nose V, Satchi-Fainaro R, Zausche B, Mulkern RV, Jaksic T, Bistrian B, Folkman J, Puder M. The route of lipid administration affects parenteral nutrition-induced hepatic steatosis in a mouse model. J Pediatr Surg. 2005 Sep;40(9):1446-53. doi: 10.1016/j.jpedsurg.2005.05.045. |
| 16923311 | Background | Calder PC. Use of fish oil in parenteral nutrition: Rationale and reality. Proc Nutr Soc. 2006 Aug;65(3):264-77. doi: 10.1079/pns2006500. |
| 9437703 | Background | Clayton PT, Whitfield P, Iyer K. The role of phytosterols in the pathogenesis of liver complications of pediatric parenteral nutrition. Nutrition. 1998 Jan;14(1):158-64. doi: 10.1016/s0899-9007(97)00233-5. |
| 15753852 | Background | Alwayn IP, Andersson C, Zauscher B, Gura K, Nose V, Puder M. Omega-3 fatty acids improve hepatic steatosis in a murine model: potential implications for the marginal steatotic liver donor. Transplantation. 2005 Mar 15;79(5):606-8. doi: 10.1097/01.tp.0000150023.86487.44. |
| 18310188 | Background | 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. |
| 24425724 | Background | Premkumar MH, Carter BA, Hawthorne KM, King K, Abrams SA. Fish oil-based lipid emulsions in the treatment of parenteral nutrition-associated liver disease: an ongoing positive experience. Adv Nutr. 2014 Jan 1;5(1):65-70. doi: 10.3945/an.113.004671. |
| 15343182 | Background | Chen CY, Tsao PN, Chen HL, Chou HC, Hsieh WS, Chang MH. Ursodeoxycholic acid (UDCA) therapy in very-low-birth-weight infants with parenteral nutrition-associated cholestasis. J Pediatr. 2004 Sep;145(3):317-21. doi: 10.1016/j.jpeds.2004.05.038. |
| 24782691 | Background | Thibault M, McMahon J, Faubert G, Charbonneau J, Malo J, Ferreira E, Mohamed I. Parenteral nutrition-associated liver disease: a retrospective study of ursodeoxycholic Acid use in neonates. J Pediatr Pharmacol Ther. 2014 Jan;19(1):42-8. doi: 10.5863/1551-6776-19.1.42. |
| 21923431 | Background | Tillman EM, Crill CM, Black DD, Hak EB, Lazar LF, Christensen ML, Huang EY, Helms RA. Enteral fish oil for treatment of parenteral nutrition-associated liver disease in six infants with short-bowel syndrome. Pharmacotherapy. 2011 May;31(5):503-9. doi: 10.1592/phco.31.5.503. |
| 24630347 | Background | Yang Q, Ayers K, Welch CD, O'Shea TM. Randomized controlled trial of early enteral fat supplement and fish oil to promote intestinal adaptation in premature infants with an enterostomy. J Pediatr. 2014 Aug;165(2):274-279.e1. doi: 10.1016/j.jpeds.2014.02.002. Epub 2014 Mar 12. |
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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