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A randomised, double-blind, controlled study of Omegaven for rescue treatment of parenteral nutrition-associated cholestasis (PNAC) in infants requiring long-term parenteral nutrition

A randomised, double-blind, controlled study of Omegaven for rescue treatment of parenteral nutrition-associated cholestasis (PNAC) in infants requiring long-term parenteral nutrition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000718
Enrollment
Unknown
Registered
2008-03-31
Start date
2008-04-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral nutrition-associated cholestasis in infants

Interventions

Two groups:Omegaven (fish oil-based parenteral lipid supplement) vs Intralipid (soy-based parenteral lipid supplement) at least 4 months

Sponsors

Department of Paediatrics, CUHK
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
No minimum to 12 Years

Inclusion criteria

Inclusion criteria: 1. developed PNAC, defined as serum conjugated bilirubin concentration >=34 mmol/L on routine weekly liver function assessment, in patients on parental nutrition; 2. expected to receive at least two more weeks of parenteral nutrition; 3. informed parental consent

Exclusion criteria

Exclusion criteria: 1. major congenital or lethal chromosomal abnormalities; 2. multiorgan failure and imminent death; 3. cholestatic jaundice secondary to other known causes e.g., congenital or acquired TORCH and syphillis infection; hepatitis B and C infection; biliary atresia and other lesions obstructing bile flow, both intrahepatic and extrahepatic

Design outcomes

Secondary

MeasureTime frame
Infant growth; blood lipid profile; coagulation status; episodes of late-onset infection over 4 months.;

Primary

MeasureTime frame
Reversal of PNAC over 4 months;

Countries

China

Contacts

Public ContactLam, Hugh Simon Hung San
hshslam@cuhk.edu.hk+852 26322211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026