TRIAL OF PREEMIE SMA SUPPLEMENTED WITH LONG CHAIN POLYUNSATURATED FATTY ACIDS

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The primary objective of this study is to evaluate the safety of long chain polyunsaturated fatty acid (LCP) supplemented preemie SMA in preterm infants. This study is a double-blind, randomized, controlled, multi- center prospective study. Patients were studied as both inpatients and outpatients. Since the last approval, we have enrolled a total of 5 patients who completed the in-hospital phase of the study protocol. These patients continued to be studied as outpatients and completed their participation in the study as of March 1997, at their 12 month evaluation. We have encountered no complications related to blood drawing and have not noticed any signs of feeding intolerance to any of the study formulas. All five patients are growing appropriately with parameters falling within the 25 and 75 percentiles of the growth chart, corrected for prematurity.