Abstract：
Gut immaturity leads to feeding difficulties in very preterm infants (<32 weeks gestation at birth). Maternal milk (MM) is the optimal diet but often absent or insufficient. We hypothesized that bovine colostrum (BC), rich in protein and bioactive components, improves enteral feeding progression, relative to preterm formula (PF), when supplemented to MM. Aim of the study is to determine whether BC supplementation to MM during the first 14 days of life shortens the time to full enteral feeding (120 mL/kg/d, TFF120).
This was a multicenter, randomized, controlled trial at seven hospitals in South China without access to human donor milk and with slow feeding progression. Infants were randomly assigned to receive BC or PF when MM was insufficient. Volume of BC was restricted by recommended protein intake (4-4.5 g/kg/d). Primary outcome was TFF120. Feeding intolerance, growth, morbidities and blood parameters were recorded to assess safety.
A total of 350 infants were recruited. BC supplementation had no effect on TFF120 in intention-to-treat analysis [n (BC) = 171, n (PF) = 179; adjusted hazard ratio, aHR: 0.82 (95% CI: 0.64, 1.06); P = 0.13]. Body growth and morbidities did not differ, but more cases of periventricular leukomalacia were detected in the infants fed BC (5/155 vs. 0/181, P = 0.06). Blood chemistry and hematology data were similar between the intervention groups.
BC supplementation during the first two weeks of life did not reduce TFF120 and had only marginal effects on clinical variables. Clinical effects of BC supplementation on very preterm infants in the first weeks of life may depend on feeding regimen and remaining milk diet.
http://www.
gov: NCT03085277.
This was a multicenter, randomized, controlled trial at seven hospitals in South China without access to human donor milk and with slow feeding progression. Infants were randomly assigned to receive BC or PF when MM was insufficient. Volume of BC was restricted by recommended protein intake (4-4.5 g/kg/d). Primary outcome was TFF120. Feeding intolerance, growth, morbidities and blood parameters were recorded to assess safety.
A total of 350 infants were recruited. BC supplementation had no effect on TFF120 in intention-to-treat analysis [n (BC) = 171, n (PF) = 179; adjusted hazard ratio, aHR: 0.82 (95% CI: 0.64, 1.06); P = 0.13]. Body growth and morbidities did not differ, but more cases of periventricular leukomalacia were detected in the infants fed BC (5/155 vs. 0/181, P = 0.06). Blood chemistry and hematology data were similar between the intervention groups.
BC supplementation during the first two weeks of life did not reduce TFF120 and had only marginal effects on clinical variables. Clinical effects of BC supplementation on very preterm infants in the first weeks of life may depend on feeding regimen and remaining milk diet.
http://www.
gov: NCT03085277.
摘要：
目的：极早产儿（出生时妊娠<32周）的肠道不成熟导致喂养困难。母乳（MM）是最佳饮食，但经常缺乏或不足。我们假设牛初乳(BC)，富含蛋白质和生物活性成分，改善肠内喂养进展，相对于早产公式(PF)，当补充到MM时。该研究的目的是确定在生命的前14天补充BC是否会缩短完全肠内喂养的时间（120mL/kg/d，TFF120)。
方法：这是一个多中心，随机化，在中国南方七家医院进行的对照试验，没有获得人类供体奶，喂养进展缓慢。当MM不足时，婴儿被随机分配接受BC或PF。建议的蛋白质摄入量（4-4.5g/kg/d）限制了BC的体积。主要结果是TFF120。喂养不耐受,增长,记录发病率和血液参数以评估安全性.
结果：共招募了350名婴儿。在意向治疗分析中，补充BC对TFF120没有影响[n（BC）=171，n（PF）=179；调整后的风险比，aHR：0.82（95%CI：0.64，1.06）；P=0.13]。身体生长和发病率没有差异，但在喂养BC的婴儿中检测到更多的脑室周围白质软化病例(5/155vs.0/181,P=0.06)。干预组之间的血液化学和血液学数据相似。
结论：在生命的前两周补充BC并没有降低TFF120，对临床变量仅有边际影响。在出生后的第一周内，补充BC对早产婴儿的临床效果可能取决于喂养方案和剩余的牛奶饮食。
背景：http://www.
结果：gov：NCT03085277。
方法：这是一个多中心，随机化，在中国南方七家医院进行的对照试验，没有获得人类供体奶，喂养进展缓慢。当MM不足时，婴儿被随机分配接受BC或PF。建议的蛋白质摄入量（4-4.5g/kg/d）限制了BC的体积。主要结果是TFF120。喂养不耐受,增长,记录发病率和血液参数以评估安全性.
结果：共招募了350名婴儿。在意向治疗分析中，补充BC对TFF120没有影响[n（BC）=171，n（PF）=179；调整后的风险比，aHR：0.82（95%CI：0.64，1.06）；P=0.13]。身体生长和发病率没有差异，但在喂养BC的婴儿中检测到更多的脑室周围白质软化病例(5/155vs.0/181,P=0.06)。干预组之间的血液化学和血液学数据相似。
结论：在生命的前两周补充BC并没有降低TFF120，对临床变量仅有边际影响。在出生后的第一周内，补充BC对早产婴儿的临床效果可能取决于喂养方案和剩余的牛奶饮食。
背景：http://www.
结果：gov：NCT03085277。
