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Trial History Detail on 2012-06-20

CUHK_CCT00161

2008-03-31

Prospective

Nil

Department of Paediatrics, CUHK

Department of Paediatrics, CUHK

N/A

Lam, Hugh Simon Hung San

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

26322211

hshslam@cuhk.edu.hk

The Chinese University of Hong Kong

Lam, Hugh Simon Hung San

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

26322211

hshslam@cuhk.edu.hk

The Chinese University of Hong Kong

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

Treatment infant parenteral lipid study

Hong Kong SAR, China

Yes

2008-02-06

Parenteral nutrition-associated cholestasis in infants

Other

parenteral lipid supplement

Omegaven (fish oil-based parenteral lipid supplement)

For as long as subject requires parenteral nutrition (may be 4 months or more)

Intralipid (soy-based parenteral lipid supplement)

Inclusion criteria: (i) developed PNAC, defined as serum conjugated bilirubin concentration ≥ 34 mmol/L on routine weekly liver function assessment, in patients on parental nutrition
(ii) expected to receive at least two more weeks of parenteral nutrition
(iii) informed parental consent

(i) major congenital or lethal chromosomal abnormalities
(ii) multiorgan failure and imminent death
(iii) 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

0 days

12 months

Both Male and Female

Interventional

Randomized

Active

Double-blind

Parallel

2008-04-30

54

Complete

Reversal of PNAC over 4 months

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

No

2013-04-05

ChiCTR-TRC-09000718

2010-05-04


Yes

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