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

September 16, 2013 updated by: Ibrahim Mohamed
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursodiol
Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.
Drug: Ursodiol

Ursodiol is given by mouth, three times a day from second value of elevated conjugated bilirubin (>33mmol/L) to the resolution of cholestasis (conjugated bilirubin <34mmol/L) If Nil per os, 3,3mg/kg/dose is given. If Nil per os is required (e.g. pre-surgery, or necrotizing enterocolitis), none is given.

If enteral feeding is under 100mL/kg/day, 6,7 mg/kg/day is given. If enteral feeding exceeds 100mL/kg/day, 10 mg/kg/day is given.

Other Names:
  • ursodeoxycholic acid
  • Urso
Placebo Comparator: placebo
A placebo suspension that looks like the ursodiol suspension used.
Drug: placebo
Placebo given in the same amount that ursodiol would be given, depending on enteral feeding and weight. It is also given three times a day, until cholestasis resolution.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibrahim Mohamed

Investigators

  • Principal Investigator: Ibrahim Mohamed, MB ChB, DIS P, St. Justine's Hospital
  • Study Director: Josianne Malo, B.Pharm, M.Sc., St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC:127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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