A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial

摘要

ObjectivesTo examine whether a mixed lipid emulsion reduces the incidence of parenteral nutrition associated cholestasis (PNAC) in extremely low birth weight (ELBW, 1.5?mg/dL [25?μmol/L] at 2 consecutive measurements). The study was powered to detect a reduction of PNAC from 25% to 10%. ResultsReasons for noneligibility of 274 infants screened were refusal to participate (n?=?16), death (n?=?10), withdrawal of treatment (n?=?5), higher order multiples (n?=?9), and parents not available for consent (n?=?4). Intention to treat analysis was carried out in 223 infants (7 infants excluded after randomization). Parenteral nutrition associated cholestasis was 11 of 110 (10.1%) in the intervention and 18 of 113 (15.9%) in the control group (P?=?.20). Multivariable analyses showed no statistically significant difference in the intention to treat (aOR 0.428, 95% CI 0.155-1.187;P?=?.10) or per protocol population (aOR 0.457, 95% CI 0.155-1.347;P?=?.16). There was no statistically significant effect on any other neonatal morbidity. ConclusionsThe incidence of parenteral nutrition associated cholestasis was not significantly reduced using a mixed lipid emulsion in ELBW infants. Trial RegistrationClinicalTrials.govNCT01585935.