使用新型人乳强化剂优化极早产儿和/或极低出生体重儿的母乳喂养：中国多中心研究。
Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China.
机构信息
Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, 399 Wanyuan Road, Minhang District, Shanghai, 201102, China.
Department of Pediatrics, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, 210004, China.
出版信息
BMC Pediatr. 2024 Jan 19;24(1):61. doi: 10.1186/s12887-024-04527-2.
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.
TRIAL REGISTRATION
This study was registered on ClinicalTrials.gov (NCT04283799).
背景
人乳强化剂（HMF）的组成最近已经得到优化。但在中国人群中，其安全性和有效性的临床证据有限。本研究旨在评估一种新的 HMF 对中国极早产儿（VPT）或极低出生体重儿（VLBW）的生长、营养状况、喂养不耐受以及主要并发症的影响。
方法
2020 年 3 月至 2021 年 4 月期间，前瞻性纳入 VPT/VLBW 婴儿进入实验组（新型 HMF，nHMF），他们在住院期间接受一种新型粉末 HMF 作为母乳喂养补充剂。对照组（cHMF）中，回顾性纳入 2018 年 1 月至 2019 年 12 月期间入院的婴儿，并根据胎龄和出生体重与 nHMF 组相匹配。他们接受了其他种类的市售 HMF。比较两组之间的体重增长速度、营养生物标志物浓度、主要并发症发生率和喂养不耐受程度。
结果
nHMF 和 cHMF 组婴儿的人口统计学和临床特征无显著差异。nHMF 组（14.0±3.5 g/kg/d）和 cHMF 组（14.2±3.8 g/kg/d）的体重增长速度无显著差异（P=0.46）。nHMF 和 cHMF 组之间，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、培养证实的败血症和住院期间喂养不耐受在内的发病率相似（所有 P 值均>0.05）。nHMF 组达到完全肠内喂养的时间[13.5（10，21）天]明显短于 cHMF 组[17（12，23）天，HR=0.67，95%CI：0.49，0.92；P=0.01]。与 cHMF 组相比，nHMF 组的血尿素氮水平随时间的下降幅度较小（β=0.6，95%CI：0.1，1.0；P=0.01）。
结论
新型 HMF 可有效促进早产儿生长，不增加主要发病率和喂养不耐受的发生。它可在我国 VPT/VLBW 婴儿中安全使用。
试验注册
本研究在 ClinicalTrials.gov 注册（NCT04283799）。
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