146 A Randomized, Doubleblind Crossover Study Comparing Rhbssl (Recombinant Human Bilesaltstimulated Lipase) and Placebo Added to Infant Formula in Preterm Infants

Abstract

Background: The rationale for enzyme replacement therapy with rhBSSL in preterm infants is to restore the natural lipase activity that is absent when mother's milk is replaced with infant formula or human pasteurized milk.

Objectives: To compare the CFA of total fat and of selected fatty acids, as well as growth and safety in preterm infants treated with 0.15 g/L rhBSSL or placebo. 33 infants with a mean (±SD) weight of 1494±195 g and GA 32.6±0.46 weeks were randomised at 3.4±1.19 weeks of life to receive one-week treatment with rhBSSL and placebo in a crossover design. 32 infants completed the study and 26 were evaluable for CFA.

Results: During rhBSSL treatment a small but not statistically significant increase in total CFA (2.1%) was observed as compared to placebo. A statisticially significant improvement in weight of 3.7 g/kg/day (95% CI:1.6 to 5.9) with rhBSSL (mean 18.1 SD 3.96) compared to placebo (mean 14.3 SD 6.49) (p=0.001) was observed. There was a trend towards improved intestinal absorption of docosahexanoic acid and arachidonic acid (7.1% and 6.8% respectively) with rhBSSL.

One serious adverse event occurred during the study but was not related to study drug. No difference in tolerability between rhBSSL and placebo was seen.

Conclusion: In this first clinical study of rhBSSL in preterm infants a statistically significant increase in weight gain was observed. After one week of treatment, there was no significant difference in CFA. The safety and tolerability profile of rhBSSL added to formula was similar compared to placebo.

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