Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

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

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.

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