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牛初乳作为极早产儿母乳强化剂的随机对照试验(FortiColos)。

Bovine colostrum as a fortifier to human milk in very preterm infants - A randomized controlled trial (FortiColos).

机构信息

Section of Comparative Pediatrics and Nutrition, University of Copenhagen, Frederiksberg, Denmark.

Section of Comparative Pediatrics and Nutrition, University of Copenhagen, Frederiksberg, Denmark; Department of Neonatology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

出版信息

Clin Nutr. 2023 May;42(5):773-783. doi: 10.1016/j.clnu.2023.03.008. Epub 2023 Mar 15.

DOI:10.1016/j.clnu.2023.03.008
PMID:37004355
Abstract

BACKGROUND

Human milk for very preterm infants need fortification for optimal growth and development but the optimal fortification product remains to be identified.

AIMS

To investigate feasibility, safety and preliminary efficacy on growth and blood biochemistry when using intact bovine colostrum (BC) as a fortifier to human milk in very preterm infants.

METHODS

In an open-label, multicenter, randomized controlled pilot trial (infants 26-31 weeks' gestation), mother's own milk or donor human milk was fortified with powdered BC (n = 115) or a conventional fortifier (CF, bovine-milk-based, n = 117) until 35 weeks' postmenstrual age. Fortifiers and additional micronutrients were added to human milk according to local guidelines to achieve optimal growth (additional protein up to +1.4 g protein/100 mL human milk). Anthropometry was recorded weekly. Clinical morbidities including necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) were recorded. Clinical biochemistry included plasma amino acid (AA) levels to assess protein metabolic responses to the new fortifier.

RESULTS

A total of 232 infants, gestational age (GA) 28.5 ± 1.4 (weeks + days), fulfilled inclusion criteria. Birthweight, GA and delta Z scores from birth to end of intervention on weight, length or head circumference did not differ between groups, nor between the subgroups of small for gestational age infants. Likewise, incidence of NEC (BC: 3/115 vs. CF: 5/117, p = 0.72, unadjusted values), LOS (BC: 23/113 vs. CF: 14/116, p = 0.08) and other morbidities did not differ. BC infants received more protein than CF infants (+10%, p < 0.05) and showed several elevated AA levels (+10-40%, p < 0.05).

CONCLUSION

Infants fortified with BC showed similar growth but received more protein and showed a moderate increase in plasma AA-levels, compared with CF. Adjustments in protein composition and micronutrients in BC-based fortifiers may be required to fully suit the needs for very preterm infants.

摘要

背景

为了促进早产儿最佳生长和发育,人乳需要强化,但最佳强化产品仍有待确定。

目的

研究使用完整牛初乳(BC)作为早产儿人乳强化剂的可行性、安全性和初步生长及血液生化疗效。

方法

在一项开放标签、多中心、随机对照试验(胎龄 26-31 周的婴儿)中,母亲的母乳或捐赠母乳用人乳强化剂(牛初乳粉,n=115)或传统强化剂(牛乳基,n=117)强化,直至校正胎龄 35 周。根据当地指南向人乳中添加强化剂和其他微量营养素,以实现最佳生长(每 100 毫升人乳额外添加蛋白质至+1.4 克)。每周记录人体测量学数据。记录包括坏死性小肠结肠炎(NEC)和晚发性败血症(LOS)在内的临床并发症。临床生化包括血浆氨基酸(AA)水平,以评估新强化剂的蛋白质代谢反应。

结果

共有 232 名婴儿(胎龄 28.5±1.4 周+天)符合纳入标准。两组之间、小胎龄儿亚组之间的体重、胎龄和从出生到干预结束时体重、身长或头围的 delta Z 评分均无差异。同样,NEC(BC:3/115 与 CF:5/117,p=0.72,未校正值)、LOS(BC:23/113 与 CF:14/116,p=0.08)和其他并发症的发生率也无差异。BC 组婴儿接受的蛋白质比 CF 组多(+10%,p<0.05),且显示出几种 AA 水平升高(+10-40%,p<0.05)。

结论

与 CF 相比,BC 强化的婴儿生长情况相似,但接受的蛋白质更多,血浆 AA 水平略有升高。可能需要调整基于 BC 的强化剂中的蛋白质组成和微量营养素,以完全满足早产儿的需求。

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