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对两种市售人乳强化剂用于健康早产儿的随机对照评估。

A randomized, controlled evaluation of two commercially available human breast milk fortifiers in healthy preterm neonates.

作者信息

Sankaran K, Papageorgiou A, Ninan A, Sankaran R

机构信息

Perinatal Research Laboratory, College of Medicine, University of Saskatchewan, Saskatoon, Canada.

出版信息

J Am Diet Assoc. 1996 Nov;96(11):1145-9. doi: 10.1016/s0002-8223(96)00295-7.

DOI:10.1016/s0002-8223(96)00295-7
PMID:8906139
Abstract

OBJECTIVE

To evaluate the added nutritional value of the two commercially available human breast milk fortifiers: Similac Natural Care (NC) and Enfamil Powder (EP).

DESIGN

A randomized controlled evaluation in healthy preterm neonates.

SETTING

Neonatal Intensive Care Unit, Royal University Hospital, Saskatoon, Saskatchewan, and Neonatal Intensive Care Unit, Jewish General Hospital, Montreal, Quebec, Canada.

SUBJECTS

Healthy preterm infants admitted to and cared for in the aforementioned neonatal intensive care units.

INTERVENTIONS

Healthy preterm neonates who were receiving expressed breast milk from their own mothers were supplemented with human milk fortifiers (NC and EP) per manufacturer's recommendations.

MAIN OUTCOME MEASURES

Gestational age and birth weight, gender, and race. At entry to and exit from the study, serum concentrations of albumin, protein, calcium, phosphorus, and alkaline phosphatase. The age at which the supplements were added and the number of days the infant remained in the hospital. Daily weight gain, head circumference, length, and height were also measured.

STATISTICAL ANALYSES PERFORMED

Student's t test was used to test the differences between the groups and within the groups at entry to and exit from the study. Fisher's exact test was used to determine differences in race, size, and gestational age in each group. When necessary, a chi 2 test was used to analyze the preponderance of either sex in each group. A Wilcoxon rank test was applied to the true exit date to determine whether the bias was comparable in each group.

RESULTS

The mean (+/- standard error) gestational age and birth weight were similar in both groups: 30 +/- 0.3 weeks and 1,314 +/- 40 g, respectively, for NC vs 29.6 +/- 0.35 weeks and 1,262 +/- 45 g, respectively, for EP. At entry to the study, values for the NC group (N = 29) were albumin 31 +/- 1.2 g/L, serum protein 48 +/- 1.4 g/L, calcium 2.4 +/- 0.03 mmol/L, phosphorus 1.85 +/- 0.08 mmol/L, alkaline phosphatase 347 +/- 27 IU/L. The values for the EP group (N = 30) were albumin 32 +/- 0.9 g/L, serum protein 49 +/- 1.4 g/L, calcium 2.4 +/- 0.4 mmol/L, phosphorus 1.9 +/- 0.1 mmol/L, alkaline phosphatase 420 +/- 34 IU/L. At the study exit, the values for the NC group were albumin 30 +/- 0.7 g/L, serum protein 45 +/- 0.9 g/L, calcium 2.4 +/- 0.3 mmol/L, phosphorus 1.96 +/- 0.07 mmol/L, and alkaline phosphatase 371 +/- 23 IU/L. The values for the EP group were albumin 32 +/- 1.0 g/L, serum protein 46.0 +/- 1.4 g/L, calcium 2.5 +/- 0.03 mmol/L, serum phosphorus 2.2 +/- 0.1, and alkaline phosphatase 367 +/- 27 IU/L. No significant differences were observed between groups at entry to and exit from the study. However, in the EP group the alkaline phosphatase decreased significantly (P = .02) from entry to exit and calcium increased significantly during the same period compared with the NC group (P = .003). The mean daily weight gain was 33 +/- 0.7 g for the NC group and 31 +/- 1 g for the EP group. The weekly gain in head circumference and body length were also similar in both groups: approximately 1 cm/week. Both groups tolerated the fortifiers well.

APPLICATIONS/CONCLUSIONS: These findings suggest that both products provide the additional nutritional support necessary for optimal overall postnatal growth in healthy preterm infants. The differences in calcium and alkaline phosphatase may be due to the differences in vitamin D content in fortifiers 88 IU/100 mL in mixed NC vs 270 IU/100 mL in mixed EP. This observation calls for careful monitoring of calcium and alkaline phosphatase values and possible adjustments of vitamin D intake when fortifiers are used for extended periods.

摘要

目的

评估两种市售人乳强化剂:雅培喜康宝(NC)和美赞臣奶粉(EP)的额外营养价值。

设计

对健康早产儿进行随机对照评估。

地点

加拿大萨斯喀彻温省萨斯卡通市皇家大学医院新生儿重症监护病房,以及加拿大魁北克省蒙特利尔市犹太总医院新生儿重症监护病房。

研究对象

入住上述新生儿重症监护病房并接受护理的健康早产儿。

干预措施

根据制造商建议,对接受其母亲挤出母乳的健康早产儿补充人乳强化剂(NC和EP)。

主要观察指标

胎龄、出生体重、性别和种族。研究开始和结束时,血清白蛋白、蛋白质、钙、磷和碱性磷酸酶浓度。添加补充剂的年龄以及婴儿住院天数。还测量了每日体重增加、头围、身长和身高。

所进行的统计分析

采用学生t检验来检验研究开始和结束时两组之间以及组内的差异。采用Fisher精确检验来确定每组中种族、大小和胎龄的差异。必要时,使用卡方检验分析每组中男女比例。对实际出院日期应用Wilcoxon秩和检验,以确定每组中的偏差是否具有可比性。

结果

两组的平均(±标准误)胎龄和出生体重相似:NC组分别为30±0.3周和1314±40克,EP组分别为29.6±0.35周和1262±45克。研究开始时,NC组(N = 29)的值为白蛋白31±1.2 g/L、血清蛋白48±1.4 g/L、钙2.4±0.03 mmol/L、磷1.85±0.08 mmol/L、碱性磷酸酶347±27 IU/L。EP组(N = 30)的值为白蛋白32±0.9 g/L、血清蛋白49±1.4 g/L、钙2.4±0.4 mmol/L、磷1.9±0.1 mmol/L、碱性磷酸酶420±34 IU/L。研究结束时,NC组的值为白蛋白30±0.7 g/L、血清蛋白45±0.9 g/L、钙2.4±0.3 mmol/L、磷1.96±0.07 mmol/L、碱性磷酸酶371±23 IU/L。EP组的值为白蛋白32±1.0 g/L、血清蛋白46.0±1.4 g/L、钙2.5±0.03 mmol/L、血清磷2.2±0.1、碱性磷酸酶367±27 IU/L。研究开始和结束时两组之间未观察到显著差异。然而,与NC组相比,EP组从研究开始到结束时碱性磷酸酶显著降低(P = 0.02),同期钙显著升高(P = 0.003)。NC组的平均每日体重增加为33±0.7克,EP组为31±1克。两组头围和身长的每周增加量也相似:约1厘米/周。两组对强化剂耐受性良好。

应用/结论:这些发现表明,两种产品都能为健康早产儿提供最佳产后总体生长所需的额外营养支持。钙和碱性磷酸酶的差异可能归因于强化剂中维生素D含量的差异(混合NC中为88 IU/100 mL,混合EP中为270 IU/100 mL)。这一观察结果要求在长期使用强化剂时仔细监测钙和碱性磷酸酶值,并可能调整维生素D摄入量。

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