Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates (URSONEONAT)
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|ClinicalTrials.gov Identifier: NCT00846963|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : September 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis||Drug: Ursodiol Drug: placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
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.
- 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. ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|