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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00846963
First received: February 17, 2009
Last updated: September 16, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) [ Time Frame: at least once a week, during cholestasis ] [ Designated as safety issue: No ]
  • Length required to minimal enteral feeding (120mL/kg/day) measured in days. [ Time Frame: From birth to outcome (usually less than 21 days) ] [ Designated as safety issue: No ]
  • Weight gain (in g/kg/day) [ Time Frame: From birth to resolution of cholestasis (very varuiable but usually less than 3 months) ] [ Designated as safety issue: No ]
  • Adverse effects linked to ursodiol [ Time Frame: From beginning to the end of the medication (average 4 weeks) ] [ Designated as safety issue: Yes ]

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
  • ursodiol
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.
Other Name: placebo

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 17, 2009
Last Updated: September 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014