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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00846963
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE February 17, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date September 17, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Lenght of parenteral nutrition associated cholestasis (in days) [ Time Frame: at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: 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 ]
  • Length required to minimal enteral feeding (120mL/kg/day) measured in days. [ Time Frame: 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) ]
  • Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication (average 4 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
  • Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: at least once a week, during cholestasis ]
  • Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ]
  • Parenteral nutrition duration (in days) [ Time Frame: From birth to cholestasis resolution ]
  • Length required to minimal enteral feeding (120mL/kg/day) mesured in days. [ Time Frame: From birth to outcome ]
  • Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis ]
  • Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Official Title  ICMJE Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cholestasis
Intervention  ICMJE
  • 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:
    • Urso
    • ursodeoxycholic acid
  • 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.
Study Arms  ICMJE
  • Experimental: Ursodiol
    Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.
    Intervention: Drug: Ursodiol
  • Placebo Comparator: placebo
    A placebo suspension that looks like the ursodiol suspension used.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2013)
26
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
50
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00846963
Other Study ID Numbers  ICMJE RC:127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ibrahim Mohamed, St. Justine's Hospital
Study Sponsor  ICMJE Ibrahim Mohamed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ibrahim Mohamed, MB ChB, DIS P St. Justine's Hospital
Study Director: Josianne Malo, B.Pharm, M.Sc. St. Justine's Hospital
PRS Account St. Justine's Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP