Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Information source: St. Justine's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholestasis
Intervention: Ursodiol (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: St. Justine's Hospital Official(s) and/or principal investigator(s):
Ibrahim Mohamed, MB ChB, DIS P, Principal Investigator, Affiliation: CHU Sainte-Justine
Josianne Malo, B.Pharm, M.Sc., Study Director, Affiliation: CHU Sainte-Justine
Overall contact:
Ibrahim Mohamed, MB ChB, DIS P(Fr), Phone: 514-345-4931, Ext: 4441, Email: ibrahim.mohamed.hsj@ssss.gouv.qc.ca
Summary
The purpose of this study is to determine whether ursodiol is effective in the treatment of
parenteral nutrition associated cholestasis in neonates.
Clinical Details
Official title: Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Length of parenteral nutrition associated cholestasis (in days)
Secondary outcome: Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin)1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level) Parenteral nutrition duration (in days) Length required to minimal enteral feeding (120mL/kg/day) mesured in days. Weight gain (in g/kg/day) Adverse effects linked to ursodiol
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Preterm or in-term newborns hospitalized in neonatal care units at CHU Sainte-Justine
between October 1st 2008 and October 1st 2010.
- 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 and Contacts
Ibrahim Mohamed, MB ChB, DIS P(Fr), Phone: 514-345-4931, Ext: 4441, Email: ibrahim.mohamed.hsj@ssss.gouv.qc.ca
CHU Sainte-Justine, Montréal, Quebec H3T 1C5, Canada; Recruiting
Ibrahim Mohamed, Email: ibrahim.mohamed.hsj@ssss.gouv.qc.ca
Ibrahim Mohamed, MB ChB, DIS Ped, Fellowship, Principal Investigator
Josianne Malo, B.Pharm, M.Sc, Sub-Investigator
Jessica McMahon, B.Pharm, Sub-Investigator
Maxime Thibault, B.Pharm, Sub-Investigator
Guillaume Faubert, B.Pharm, Sub-Investigator
Julie Charbonneau, B.Pharm, Sub-Investigator
Ema Ferreira, B.Pharm, M.Sc, Pharm.D, Sub-Investigator
Denis Lebel, B.Pharm, M.Sc, Sub-Investigator
Jean-François Bussières, B.Pharm, M.Sc, MBA, FSCHP, Sub-Investigator
Valérie Marchand, MD, FRCPC, Sub-Investigator
Additional Information
Related publications: 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. 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. 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. Venigalla S, Gourley GR. Neonatal cholestasis. Semin Perinatol. 2004 Oct;28(5):348-55. Review. McKiernan PJ. Neonatal cholestasis. Semin Neonatol. 2002 Apr;7(2):153-65. Review.
Starting date: October 2008
Ending date: October 2010
Last updated: September 17, 2009
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