drugset / Trial / NCT00846963
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
Timeline
- Start
- 2008-10
- Primary completion
- 2012-12
- Completion
- 2013-03
Publications
- Background Al-Hathlol K, Al-Madani A, Al-Saif S, Abulaimoun B, Al-Tawil K, El-Demerdash A. Ursodeoxycholic acid therapy for intractable total parenteral nutrition-associated cholestasis in surgical very low birth weight infants. Singapore Med J. 2006 Feb;47(2):147-51.
- Background Arslanoglu S, Moro GE, Tauschel HD, Boehm G. Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008 Feb;46(2):228-31. doi: 10.1097/MPG.0b013e3181560524.
- 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.
- Background Venigalla S, Gourley GR. Neonatal cholestasis. Semin Perinatol. 2004 Oct;28(5):348-55. doi: 10.1053/j.semperi.2004.09.008.
- Background McKiernan PJ. Neonatal cholestasis. Semin Neonatol. 2002 Apr;7(2):153-65. doi: 10.1053/siny.2002.0103.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ursodeoxycholic Acid | Small molecule | 3.3 mg/kg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 6.7 mg/kg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 10 mg/kg | Oral |