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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846963
First Posted: February 19, 2009
Last Update Posted: September 17, 2013
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.
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital
  Purpose
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

Condition Intervention Phase
Cholestasis Drug: Ursodiol Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ibrahim Mohamed, St. Justine's Hospital:

Primary Outcome Measures:
  • 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:
  • 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) ]

Enrollment: 26
Study Start Date: October 2008
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00846963


Locations
Canada, Quebec
CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Ibrahim Mohamed, Assisstant professor of pediatrics, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00846963     History of Changes
Other Study ID Numbers: RC:127
First Submitted: February 17, 2009
First Posted: February 19, 2009
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:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents