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Completed

NCT Number: NCT00846963

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

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

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Key information

Conditions

Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ursodiol

Drug

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

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ibrahim Mohamed

Other

Registry information

Acronym: URSONEONAT

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Feb 19, 2009
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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