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

INTERVENTION: Two groups:10% Omegaven (fish oil‐based parenteral lipid supplement) 1.5 g/kg/day versus 10% Intralipid (soy‐based parenteral lipid supplement) 1.5 g/kg/day, for as long as subject requires parenteral nutrition (may be 4 months or more) vs Intralipid (soy‐based parenteral lipid supplement) at least 4 months, respectively; CONDITION: Parenteral nutrition‐associated cholestasis (PNAC) PRIMARY OUTCOME: Development of PNAC over 4 months; SECONDARY OUTCOME: Infant growth; blood lipid profile; coagulation status; episodes of late‐on infection over 4 months.; 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