Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.
Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.
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低剂量的静脉注射大豆油乳液可预防早产新生儿的胆汁淤积。
DOI：
10.1177/0148607114540005
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发表时间：
2016-03
期刊：
影响因子：
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通讯作者：
Ehrenkranz RA
中科院分区：
文献类型：
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作者：
Levit OL;Calkins KL;Gibson LC;Kelley-Quon L;Robinson DT;Elashoff DA;Grogan TR;Li N;Bizzarro MJ;Ehrenkranz RA
早产儿依靠静脉注射脂肪乳剂来提供必需的脂肪酸和卡路里。以大豆为基础的静脉注射脂肪乳剂(S-IFE)的剂量与肠外营养相关性肝病有关。本研究的目的是确定小剂量S-IFE对早产儿胆汁淤积是否是一种安全有效的预防策略。这是一项针对胎龄(GA)≤为29周的婴儿的多中心随机对照试验。生命48小时的受试者随机接受低剂量(1g/kg/d)或对照组(约3g/kg/d)的S-IFE治疗。主要结果是胆汁淤积，定义为在出生28天时直接胆红素≥占总胆红素的15%，或在14天肠外营养后完全肠内喂养(以较晚者为准)。次要结果包括生长、住院时间、死亡和主要新生儿发病率。入选新生儿136例(低血压组67例，对照组69例)。两组患者的基线特征相似。当Low组与对照组相比，主要结果无差异(69%vs63%，95%CI(−0.1，0.22，p=0.45))。与对照组相比，低剂量组摄入的S-IFE和总卡路里均较少(分别为p<；0.001和p=0.03)，而28DOL时体重、身长和头围、排泄量和时间的差异均无统计学意义(p>；0.2)。与对照剂量相比，低剂量S-IFE与胆汁淤积或生长的减少无关。
Premature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition associated liver disease. This study’s purpose was to determine if low dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates. This is a multicenter randomized controlled trial in infants with a gestation age (GA) ≤ 29 weeks. Subjects < 48 hours of life were randomized to receive a low (1g/kg/day) or control dose (approximately 3g/kg/day) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥ 15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of parenteral nutrition. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities. 136 neonates (67 and 69 in the low and control group, respectively) were enrolled. Baseline characteristic were similar for the two groups. When the low group was compared to the control group, there was no difference in the primary outcome (69% vs. 63%, 95% CI (−0.1, 0.22), p=0.45). While the low group received less S-IFE and total calories over time compared to the control group (p<0.001 and p=0.03, respectively) weight, length and head circumference at 28 DOL, discharge, and over time were not different (p>0.2 for all). Compared to the control dose, low dose S-IFE was not associated with a reduction in cholestasis or growth.