Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Phase 2

Completed

• Conditions: Cholestasis
• Interventions: Drug: placebo; Drug: Ursodiol

• Registration Number: NCT00846963
• Lead Sponsor: Ibrahim Mohamed

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 32 weeks or more than 32 weeks of gestation.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	A placebo suspension that looks like the ursodiol suspension used.
Ursodiol	Ursodiol	Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.

Primary Outcome Measures

Name	Time	Method
Length of parenteral nutrition associated cholestasis (in days)	at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) average of 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Weight gain (in g/kg/day)	From birth to resolution of cholestasis (very varuiable but usually less than 3 months)
Adverse effects linked to ursodiol	From beginning to the end of the medication (average 4 weeks)
Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin)	at least once a week, during cholestasis
1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level)	at least once a week, during cholestasis
Length required to minimal enteral feeding (120mL/kg/day) measured in days.	From birth to outcome (usually less than 21 days)

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada