Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ibrahim Mohamed
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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