背景:最近已经优化了人乳强化剂(HMF)组合物。但其安全性和有效性的临床证据在中国人群中有限。这项研究的目的是评估一种新的HMF对生长的影响,营养状况,喂养不耐受,中国极早产(VPT)或极低出生体重(VLBW)婴儿的主要发病率。
方法:将2020年3月至2021年4月收治的VPT/VLBW婴儿前瞻性纳入实验(新的HMF,nHMF)组,他在住院期间接受了一种新的HMF粉作为母乳喂养补充剂。2018年1月至2019年12月收治的对照组(cHMF)婴儿,纳入回顾性研究,并与nHMF组婴儿的胎龄和出生体重相匹配。他们收到了其他种类的市售HMF。增重速度,营养生物标志物的浓度,主要发病率,比较两组喂养不耐受情况。
结果:nHMF和cHMF组婴儿的人口统计学和临床特征具有可比性。nHMF组(14.0±3.5g/kg/d)与cHMF组(14.2±3.8g/kg/d,P=0.46)的增重速度差异无统计学意义。发病率,包括坏死性小肠结肠炎,支气管肺发育不良,早产儿视网膜病变,培养证实的脓毒症,住院期间nHMF和cHMF之间的喂养不耐受,相似(所有P值>0.05)。nHMF组实现全肠内喂养的时间[13.5(10,21)天]明显短于cHMF组[17(12,23)天,HR=0.67,95CI:0.49,0.92;P=0.01]。与cHMF组相比,nHMF组血尿素氮水平随时间的下降较小(β=0.6,95CI:0.1,1.0;P=0.01)。
结论:新型HMF能有效促进早产儿的生长,且不增加早产儿的主要发病率和喂养不耐受的发生率。可用于中国VPT/VLBW婴儿。
背景:本研究在ClinicalTrials.gov(NCT04283799)上注册。
BACKGROUND: Human milk fortifier (HMF) composition has been optimized recently. But clinical evidence of its safety and efficacy is limited in Chinese population. The aim of this study was to evaluate effects of a new HMF in growth, nutritional status, feeding intolerance, and major morbidities among very preterm (VPT) or very low birth weight (VLBW) infants in
China.
METHODS: VPT/VLBW infants admitted from March 2020 to April 2021 were prospectively included in the experimental (new HMF, nHMF) group, who received a new powdered HMF as a breast milk feeding supplement during hospitalization. Infants in the control group (cHMF) admitted from January 2018 to December 2019, were retrospective included, and matched with nHMF group infants for gestational age and birth weight. They received other kinds of commercially available HMFs. Weight gain velocity, concentrations of nutritional biomarkers, incidence of major morbidities, and measures of feeding intolerance were compared between the two groups.
RESULTS: Demographic and clinical characteristics of infants in nHMF and cHMF groups were comparable. Weight gain velocity had no significant difference between the nHMF (14.0 ± 3.5 g/kg/d) and the cHMF group (14.2 ± 3.8 g/kg/d; P = 0.46). Incidence of morbidities, including necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity, culture-confirmed sepsis, and feeding intolerance during hospitalization between nHMF and cHMF, were similar (all P-values > 0.05). The time to achieve full enteral feeding [13.5 (10, 21) days] in the nHMF group was significantly shorter than that in the cHMF group [17 (12, 23) days, HR = 0.67, 95%CI: 0.49, 0.92; P = 0.01]. Compared with cHMF group, the decrease of blood urea nitrogen level over time in nHMF group was smaller (β = 0.6, 95%CI:0.1, 1.0; P = 0.01).
CONCLUSIONS: The new HMF can promote growth of preterm infants effectively without increasing the incidence of major morbidity and feeding intolerance. It can be used feasible in Chinese VPT/VLBW infants.
BACKGROUND: This study was registered on ClinicalTrials.gov (NCT04283799).