Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
NCT ID: NCT00846963
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
26 participants
INTERVENTIONAL
2008-10-31
2013-03-31
Brief Summary
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Detailed Description
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It includes all neonates with stratification of less than and equal to 32 weeks or more than 32 weeks of gestation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ursodiol
Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.
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.
placebo
A placebo suspension that looks like the ursodiol suspension used.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be receiving parenteral nutrition (either partial or total) at the diagnosis of cholestasis.
* Parental Consent must be obtained.
Exclusion Criteria
* 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
ALL
No
Sponsors
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Ibrahim Mohamed
OTHER
Responsible Party
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Ibrahim Mohamed
Assisstant professor of pediatrics
Principal Investigators
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Ibrahim Mohamed, MB ChB, DIS P
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Josianne Malo, B.Pharm, M.Sc.
Role: STUDY_DIRECTOR
St. Justine's Hospital
Locations
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CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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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. doi: 10.1097/MPG.0b013e3181560524.
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.
Venigalla S, Gourley GR. Neonatal cholestasis. Semin Perinatol. 2004 Oct;28(5):348-55. doi: 10.1053/j.semperi.2004.09.008.
McKiernan PJ. Neonatal cholestasis. Semin Neonatol. 2002 Apr;7(2):153-65. doi: 10.1053/siny.2002.0103.
Other Identifiers
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RC:127
Identifier Type: -
Identifier Source: org_study_id