Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

NCT ID: NCT00846963


Title
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Purpose
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
Details
This is the first randomised controlled study that address the question of the role of ursodiol as treatment of cases of PNAC. It includes all neonates with stratification of less than and equal to 32 weeks or more than 32 weeks of gestation.
Conditions
Cholestasis
Keywords
parenteral nutrition associated cholestasis in neonates, parenteral nutrition induced cholestasis in preterms, Bile duct obstruction, biliary stasis
Source
St. Justine's Hospital
Sponsors
Ibrahim Mohamed
Status
Completed
Acronym
URSONEONAT
Last Updated
15 Sep 2013
URL
Official Link
Citations/Publications
McKiernan PJ. Neonatal cholestasis. Semin Neonatol. 2002 Apr;7(2):153-65. Review.

Venigalla S, Gourley GR. Neonatal cholestasis. Semin Perinatol. 2004 Oct;28(5):348-55. Review.

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.

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.

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.

Locations
Canada