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.
2013-04-05
Yes
N/A
|
|
|
|
|
---|---|---|---|---|
No documents yet. |