Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates (URSONEONAT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates|
- 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. ] [ Designated as safety issue: No ]
- Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: at least once a week, during cholestasis ] [ Designated as safety issue: No ]
- 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ] [ Designated as safety issue: No ]
- Length required to minimal enteral feeding (120mL/kg/day) measured in days. [ Time Frame: From birth to outcome (usually less than 21 days) ] [ Designated as safety issue: No ]
- Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis (very varuiable but usually less than 3 months) ] [ Designated as safety issue: No ]
- Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication (average 4 weeks) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.
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.
Placebo Comparator: placebo
A placebo suspension that looks like the ursodiol suspension used.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846963
|Montréal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Ibrahim Mohamed, MB ChB, DIS P||St. Justine's Hospital|
|Study Director:||Josianne Malo, B.Pharm, M.Sc.||St. Justine's Hospital|