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Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

NCT00846963 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-09-17

No results posted yet for this study

Summary

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

Conditions

  • Cholestasis

Interventions

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.

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.

Sponsors & Collaborators

  • Ibrahim Mohamed

    lead OTHER

Principal Investigators

  • Ibrahim Mohamed, MB ChB, DIS P · St. Justine's Hospital

  • Josianne Malo, B.Pharm, M.Sc. · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846963 on ClinicalTrials.gov