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.
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。