Minimization of IntraLipid Versus Omegaven

Cholestasis Clinical Trial

— MILOve  

Official title:

A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01247012
• Other study ID #: MILOVE-134698
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 23, 2010
• Last updated: September 6, 2011
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2011
• Source: Children's & Women's Health Centre of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

Description:

Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises >100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• infants admitted to neonatal intensive care unit

• severe cholestasis, defined as conjugated bilirubin greater than 35

• receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days

• signed consent

Exclusion Criteria:

• hepatitis (TORCH or other viral infection)

• primary liver disease as etiology of cholestasis

• clinically severe bleeding not able to be managed with routine measures

• lethal congenital abnormalities

• congenital heart disease associated with right heart dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Liver Diseases
• Parenteral Nutrition Associated Liver Disease (PNALD)

Intervention

Dietary Supplement:
• Omegaven
Omegaven 1g/kg/day until infant receiving full enteral feeds
• Lipid minimization
1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)

Locations

Country	Name	City	State
Canada	Children's & Women's Health Centre of BC	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's & Women's Health Centre of British Columbia	Child and Family Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	"Success" of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol.	up to 1 year	No
Primary	Clinical endpoint	The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization	up to 1 year	No
Secondary	Total duration of parenteral nutrition		up to 1 year	No
Secondary	Growth		up to 1 year	Yes