NCT00846963

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ibrahim Mohamed · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Interventions

Type	Name	Description
DRUG	Ursodiol	Ursodiol is given by mouth, three times a day from second value of elevated conjugated bilirubin (\>33mmol/L) to the resolution of cholestasis (conjugated bilirubin \<34mmol/L) If Nil per os, 3,3mg/kg/dose is given. If Nil per os is required (e.g. pre-surgery, or necrotizing enterocolitis), none is given. If enteral feeding is under 100mL/kg/day, 6,7 mg/kg/day is given. If enteral feeding exceeds 100mL/kg/day, 10 mg/kg/day is given.
DRUG	placebo	Placebo given in the same amount that ursodiol would be given, depending on enteral feeding and weight. It is also given three times a day, until cholestasis resolution.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2009-02-19
• Last updated: 2013-09-17

Locations

1 site across 1 country: Canada