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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. Identifier: NCT00846963
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : September 17, 2013
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital

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

Condition or disease Intervention/treatment Phase
Cholestasis Drug: Ursodiol Drug: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Study Start Date : October 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

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:
  • Urso
  • ursodeoxycholic acid

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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin) [ Time Frame: at least once a week, during cholestasis ]
  2. 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ]
  3. Length required to minimal enteral feeding (120mL/kg/day) measured in days. [ Time Frame: From birth to outcome (usually less than 21 days) ]
  4. Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis (very varuiable but usually less than 3 months) ]
  5. Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication (average 4 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846963

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Canada, Quebec
CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Ibrahim Mohamed
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Principal Investigator: Ibrahim Mohamed, MB ChB, DIS P St. Justine's Hospital
Study Director: Josianne Malo, B.Pharm, M.Sc. St. Justine's Hospital
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Responsible Party: Ibrahim Mohamed, Assisstant professor of pediatrics, St. Justine's Hospital Identifier: NCT00846963    
Other Study ID Numbers: RC:127
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013
Keywords provided by Ibrahim Mohamed, St. Justine's Hospital:
parenteral nutrition associated cholestasis in neonates
parenteral nutrition induced cholestasis in preterms
Bile duct obstruction
biliary stasis
Additional relevant MeSH terms:
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Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents