Status:
COMPLETED
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Lead Sponsor:
Ibrahim Mohamed
Conditions:
Cholestasis
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
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 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 3...
Eligibility Criteria
Inclusion
- Preterm or in-term newborns hospitalized in neonatal care units at CHU Sainte-Justine between October 1st 2008 and October 1st 2011.
- Must be receiving parenteral nutrition (either partial or total) at the diagnosis of cholestasis.
- Parental Consent must be obtained.
Exclusion
- Active urinary tract infection
- Presence of clinical signs(acholic stool) of or ultrasound evidence of biliary tract anomalies.
- Positive TORCH infections(Toxoplasmosis, Other infections, Rubella, Cytomegalovirus, Herpes simplex virus)
- Known short bowel syndrome
- Known congenital hypothyroidism
- Known genetic disorders associated with cholestasis like galactosemia, phenylcytonuria, antitrypsin 1 deficiency... etc
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00846963
Start Date
October 1 2008
End Date
March 1 2013
Last Update
September 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5