Reducing soybean lipid emulsion (SLE) dose may prevent parenteral nutrition-associated cholestasis (PNAC) but effects on growth and neurodevelopment are unknown. The purpose of this study was to evaluate the effect of reduced dose SLE on growth and neurodevelopment. Surgical neonates at 4 centers were randomized to standard SLE (3 g/kg/day) or reduced SLE (1 g/kg/day) over a 12-week period. Bilirubin levels and growth parameters were measured baseline and weekly while on study. The effects of time and group on direct bilirubin and growth were evaluated with a linear mixed effects model. Neurodevelopmental outcomes were assessed at 12- and 24-months corrected gestational age. Twenty-one individuals were randomized (standard dose = 9, reduced dose = 12). Subjects in the reduced dose group had slower rates of direct bilirubin increase and overall levels decreased earlier than those in the standard dose group. There was a trend toward a faster direct bilirubin decrease in the reduced dose group (p = 0.07 at day 84). There were no differences in the rates of change in weight (p = 0.352 at day 84) or height Z-scores (p = 0.11 at day 84) between groups. One subject in the reduced dose group had abnormal neurodevelopmental testing at 24 months. Surgical neonates randomized to a reduced dose of SLE had improved trends in direct bilirubin levels without clinically significant differences in overall growth and neurodevelopment. Randomized Controlled Trial. II.

中文翻译：

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使用减少剂量的大豆脂质乳剂预防肠外营养相关的胆汁淤积：一项多中心随机试验

减少大豆脂乳 (SLE) 剂量可能会预防肠外营养相关胆汁淤积 (PNAC)，但对生长和神经发育的影响尚不清楚。本研究的目的是评估减少剂量的 SLE 对生长和神经发育的影响。 4 个中心的手术新生儿在 12 周内被随机分为标准 SLE（3 g/kg/天）或降低 SLE（1 g/kg/天）。研究期间每周测量基线和每周的胆红素水平和生长参数。使用线性混合效应模型评估时间和组对直接胆红素和生长的影响。在 12 个月和 24 个月的校正胎龄时评估神经发育结果。 21 名受试者被随机分配（标准剂量 = 9，减少剂量 = 12）。与标准剂量组相比，减少剂量组的受试者直接胆红素增加速度较慢，总体水平下降较早。减少剂量组有直接胆红素下降更快的趋势（第 84 天时 p = 0.07）。各组之间的体重变化率（第 84 天时 p = 0.352）或身高 Z 分数（第 84 天时 p = 0.11）没有差异。减少剂量组中的一名受试者在 24 个月时出现神经发育测试异常。随机接受减少 SLE 剂量的手术新生儿的直接胆红素水平趋势有所改善，但总体生长和神经发育没有临床显着差异。随机对照试验。二.