Clinical trial NCT00846963: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Official title: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cholestasis
Keywords: parenteral nutrition associated cholestasis in neonates
parenteral nutrition induced cholestasis in preterms
Bile duct obstruction
biliary stasis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Length of parenteral nutrition associated cholestasis (in days)
timeFrame: at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) average of 4 weeks.
Secondary outcomes:
measure: Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin)
timeFrame: at least once a week, during cholestasis
measure: 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level)
timeFrame: at least once a week, during cholestasis
measure: Length required to minimal enteral feeding (120mL/kg/day) measured in days.
timeFrame: From birth to outcome (usually less than 21 days)
measure: Weight gain (in g/kg/day)
timeFrame: From birth to resolution of cholestasis (very varuiable but usually less than 3 months)
measure: Adverse effects linked to ursodiol
timeFrame: From beginning to the end of the medication (average 4 weeks)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Ibrahim Mohamed, MB ChB, DIS P
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Justine's Hospital
name: Josianne Malo, B.Pharm, M.Sc.
role: STUDY_DIRECTOR
References:
citation: Al-Hathlol K, Al-Madani A, Al-Saif S, Abulaimoun B, Al-Tawil K, El-Demerdash A. Ursodeoxycholic acid therapy for intractable total parenteral nutrition-associated cholestasis in surgical very low birth weight infants. Singapore Med J. 2006 Feb;47(2):147-51.
citation: Arslanoglu S, Moro GE, Tauschel HD, Boehm G. Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008 Feb;46(2):228-31. doi: 10.1097/MPG.0b013e3181560524.
citation: Chen CY, Tsao PN, Chen HL, Chou HC, Hsieh WS, Chang MH. Ursodeoxycholic acid (UDCA) therapy in very-low-birth-weight infants with parenteral nutrition-associated cholestasis. J Pediatr. 2004 Sep;145(3):317-21. doi: 10.1016/j.jpeds.2004.05.038.
citation: Venigalla S, Gourley GR. Neonatal cholestasis. Semin Perinatol. 2004 Oct;28(5):348-55. doi: 10.1053/j.semperi.2004.09.008.
citation: McKiernan PJ. Neonatal cholestasis. Semin Neonatol. 2002 Apr;7(2):153-65. doi: 10.1053/siny.2002.0103.