Thanh Le Quang, Chen Yipu, Hartweg Mickaël, Thi Nguyen Tu Anh
Tu Du Hospital, Hồ Chí Minh, Viet Nam.
Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé SA, Vevey, Switzerland.
Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4.
Preterm formulas containing greater protein:energy ratio are beneficial for non-breastfed infants, since protein is critical for promoting catch-up growth and synthesis of lean body mass. Additionally, formulas containing enriched sn-2 palmitate (sn-2) and reduced medium chain triglycerides (MCTs) may support better feeding tolerance and nutrient utilization.
The objective of this randomized, controlled, double-blinded clinical trial is to evaluate growth, feeding tolerance and nutritional biomarkers of preterm infants with birth weight ≤2000g and gestational age ≤33wks from one neonatal unit in Vietnam receiving experimental formula (EF, n = 80) containing higher protein level of 3.4 g/100 kcal and improved fat blend with enriched sn-2 and modified level of MCTs or isocaloric control formula (CF, n = 80) containing protein level of 2.9 g/100 kcal and standard fat blend. The differences in weight gain (g/d; primary endpoint) from day 1 (D1) of full enteral feeding (FEF) until D21 between groups was evaluated for non-inferiority (margin = -2.5 g/d) and superiority (margin = 0 g/d).
Mean weight gain was 3.09 g/d greater in EF than CF; the lower limit of 95% CI (0.31 g/d) exceeded both non-inferiority and superiority margins. There was no significant difference in length-for-age and head circumference-for-age z-score. By D79, the mean change in weight-for-age z-scores from D1 in EF group (+0.76 SDs) surpassed the criteria for catch-up growth (+0.67 SDs). Infants in the EF group (vs. CF) tended to have softer stools (EF = 3.2 ± 0.59 vs. CF = 3.4 ± 0.58; P = 0.07) based on 5-point scale (1 = watery, 5 = hard). Difference in blood urea nitrogen and biomarkers for bone mineral status (i.e., plasma phosphorus, alkaline phosphatase and urinary calcium/phosphorus ratio) between EF and CF on FEF Day 21 reached statistical significance (P < 0.05) but all mean values stayed within normal clinical ranges for both groups.
Preterm formula with greater protein:energy ratio and new fat blend is safe, nutritionally suitable, well-tolerated, and improves catch-up weight gain of preterm infants. Clinical trial registry identifier is NCT03055052 (ClinicalTrials.gov).
蛋白质能量比更高的早产儿配方奶粉对非母乳喂养的婴儿有益，因为蛋白质对于促进追赶生长和瘦体重合成至关重要。此外，含有丰富sn-2棕榈酸酯（sn-2）和减少中链甘油三酯（MCTs）的配方奶粉可能有助于更好的喂养耐受性和营养利用。
这项随机、对照、双盲临床试验的目的是评估来自越南一个新生儿病房的出生体重≤2000g且胎龄≤33周的早产儿的生长、喂养耐受性和营养生物标志物。这些早产儿接受实验配方奶粉（EF，n = 80），其蛋白质水平较高，为3.4 g/100 kcal，并改进了脂肪配方，含有丰富的sn-2且调整了MCTs水平；或接受等热量对照配方奶粉（CF，n = 80），其蛋白质水平为2.9 g/100 kcal且脂肪配方为标准配方。评估两组从完全肠内喂养（FEF）第1天（D1）到第21天体重增加（g/d；主要终点）的差异，以判断非劣效性（界值 = -2.5 g/d）和优越性（界值 = 0 g/d）。
EF组的平均体重增加比CF组多3.09 g/d；95%置信区间的下限（0.31 g/d）超过了非劣效性和优越性界值。年龄别身长和年龄别头围z评分无显著差异。到第79天，EF组从D1开始的年龄别体重z评分的平均变化（+0.76标准差）超过了追赶生长的标准（+0.67标准差）。基于5分制（1 = 水样便，5 = 硬便），EF组婴儿（与CF组相比）的粪便往往更软（EF = 3.2 ± 0.59 vs. CF = 3.4 ± 0.58；P = 0.07）。在FEF第21天，EF组和CF组之间的血尿素氮以及骨矿物质状态生物标志物（即血浆磷、碱性磷酸酶和尿钙/磷比值）的差异达到统计学意义（P < 0.05），但两组的所有平均值均保持在正常临床范围内。
蛋白质能量比更高且脂肪配方新颖的早产儿配方奶粉安全、营养适宜、耐受性良好，并能改善早产儿的追赶性体重增加。临床试验注册标识符为NCT03055052（ClinicalTrials.gov）。
