CUHK_CCT00160
2008-03-31
Prospective
N/A
Department of Paediatrics, CUHK
Department of Paediatrics, CUHK
N/A
Not Applicable
Lam, Hugh Simon Hung San
Department of Paediatrics, 6/F Clinical Sciences Building, PWH
35052211
hshslam@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong, China
Lam, Hugh Simon Hung San
Department of Paediatrics, 6/F Clinical Sciences Building, PWH
35052211
hshslam@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong, China
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
探討魚油(Omegaven)預防腸道外營養導致肝損傷的效果
Prevention of PNAC by omegaven
Hong Kong SAR, China
Yes
2008-02-06
Joint CUHK-NTEC Clinical Research Ethics Committee
CRE-2007.462-T
Parenteral nutrition-associated cholestasis (PNAC)
Other
parenteral lipid supplement
Omegaven (fish oil-based parenteral lipid supplement)
10% Omegaven
1.5 g/kg/day
For as long as subject requires parenteral nutrition (may be 4 months or more)
continuous intravenous infusion
Intralipid (soy-based parenteral lipid supplement)
10% Intralipid
1.5 g/kg/day
For as long as subject requires parenteral nutrition (may be 4 months or more)
continuous intravenous infusion
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
Randomised controlled trial
Active
Double-blind
Parallel
3
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.
2020-04-26
ChiCTR-TRC-08000717
2010-05-04
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