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Trial History Detail on 2008-03-31

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

hshslam@cuhk.edu.hk

Lam, Hugh Simon Hung San

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

hshslam@cuhk.edu.hk

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

Preterm infant parenteral lipid study

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) gestation < 32 weeks; (ii) birth weight < 1500 g; (iii) serum conjugated bilirubin concentration > 34 mmol/L; (iv) 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).

Randomized

Active

Double-blind

Parallel

2008-04-30

54

Not Yet Recruiting

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


Yes

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