US Department of Agriculture (USDA)/Agricultural Research Service (ARS), Children's Nutrition Research Center, Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX.
J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.
To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control).
In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded -3 g/kg/day.
There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution (P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d.
Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants.
评估接受纯人乳（HM）饮食和 HM 衍生乳膏补充剂（乳膏）的早产儿的体重增加（g/kg/d）是否至少与人乳喂养的标准喂养方案（对照组）相当。
在一项前瞻性非劣效性、随机、非盲研究中，将出生体重为 750-1250g 的婴儿随机分配至对照组或乳膏组。对照组接受母亲的母乳或捐赠人乳和捐赠人乳衍生的强化剂。如果使用近红外 HM 分析仪检测到 HM 的能量密度<20kcal/oz，则乳膏组接受 HM 衍生乳膏补充剂。婴儿继续按照方案进行，直到胎龄 36 周。主要结局包括生长速度和使用的捐赠人乳衍生强化剂的量。如果单侧 95%CI 下限差值大于-3g/kg/d，则建立非劣效性假设。
除了种族分布（P=0.02）外，78 名研究婴儿的基线人口统计学特征在两组之间没有差异。乳膏组（n=39）的体重（14.0±2.5 vs 12.4±3.0g/kg/d，P=0.03）和长度（1.03±0.33 vs 0.83±0.41cm/wk，P=0.02）速度优于对照组（n=39）。两组使用的强化剂量无显著差异。差异（乳膏-对照组）的单侧 95%CI 下限为 0.38g/kg/d。
接受 HM 衍生乳膏强化 HM 的早产儿体重和长度增加速度优于对照组。HM 衍生乳膏应被视为纯 HM 饮食的辅助补充剂，以提高早产儿的生长速度。
