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Trial History Detail on 2011-02-08

CUHK_CCT00160

2008-03-31

Prospective

N/A

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 randomized, double-blind, controlled study of Omegaven for prophylaxis against parenteral nutrition-associated cholestasis (PNAC) in infants requiring prolonged parenteral nutrition

A randomized, double-blind, controlled study of Omegaven for prophylaxis against parenteral nutrition-associated cholestasis (PNAC) in infants requiring prolonged parenteral nutrition

Prevention of PNAC by omegaven

Hong Kong SAR, China

Yes

2008-02-06

Parenteral nutrition-associated cholestasis (PNAC)

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) newborn infants without PNAC at the time of randomization; (ii) anatomical/functional short bowel syndrome or expected to be nil by mouth for > 4 weeks; (iii) informed parenteral consent

Exclusion criteria: (i) major congenital or lethal chromosomal abnormalities; (ii) multiorgan failure and imminent death; (iii) cholestatic jaundice secondary to known cause other than parenteral nutrition associated cholestasis (PNAC).

0 days

12 months

Both Male and Female

Interventional

Randomized

Active

Double-blind

Parallel

2008-04-30

26

Recruiting

Development of PNAC over 4 months

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

No

2020-04-26

ChiCTR-TRC-09000717

2010-05-04


Yes

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