Clinical Trial: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Brief Summary: The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

Detailed Summary:

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.


Sponsor: Ibrahim Mohamed

Current Primary Outcome: Length of parenteral nutrition associated cholestasis (in days) [ Time Frame: at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) average of 4 weeks. ]

Original Primary Outcome: Lenght of parenteral nutrition associated cholestasis (in days) [ Time Frame: at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) ]

Current Secondary Outcome:

  • Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: at least once a week, during cholestasis ]
  • 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ]
  • Length required to minimal enteral feeding (120mL/kg/day) measured in days. [ Time Frame: From birth to outcome (usually less than 21 days) ]
  • Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis (very varuiable but usually less than 3 months) ]
  • Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication (average 4 weeks) ]


Original Secondary Outcome:

  • Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: at least once a week, during cholestasis ]
  • Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ]
  • Parenteral nutrition duration (in days) [ Time Frame: From birth to cholestasis resolution ]
  • Length required to minimal enteral feeding (120mL/kg/day) mesured in days. [ Time Frame: From birth to outcome ]
  • Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis ]
  • Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication ]


Information By: St. Justine's Hospital

Dates:
Date Received: February 17, 2009
Date Started: October 2008
Date Completion:
Last Updated: September 16, 2013
Last Verified: September 2013