Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Ibrahim Mohamed26 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cholestasis

Interventions

UrsodiolDRUG

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.

placeboDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

CHU Sainte-Justine

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

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)

Data from ClinicalTrials.gov

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