Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates (URSONEONAT)

Ibrahim Mohamed

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cholestasis

Treatments

Drug: placebo

Drug: Ursodiol

Study type

Interventional

Funder types

Other

Identifiers

RC:127

Details and patient eligibility

About

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

Full 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 32 weeks or more than 32 weeks of gestation.

Enrollment

26 patients

Sex

All

Volunteers

No Healthy Volunteers

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