Berrington Janet, Johnson Mark, Garg Shalabh, Stewart Christopher, Lamb Christopher, Palmer Jeremy, Embleton Nicholas
Newcastle Neonatal Services, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
J Pediatr Gastroenterol Nutr. 2025 Feb;80(2):336-344. doi: 10.1002/jpn3.12431. Epub 2024 Dec 11.
To compare faecal calprotectin, plasma amino acids and clinical outcomes in preterm infants receiving powdered human milk-based fortifier (PHMF) compared to powdered bovine milk-based fortifier (PBMF) in preterm infants on an otherwise exclusive human milk diet.
A randomised controlled trial in infants <32 weeks of gestation or <1500 g who only received human milk and had reached full enteral feeds (150 mL/kg/day), without pre-existing gastrointestinal morbidity. Primary outcome was faecal calprotectin within 21 days of starting fortification; secondary outcomes were calprotectin at discharge, plasma amino acids and clinical outcomes, including growth and neonatal morbidities.
The trial stopped early after the manufacturer's withdrawal of PHMF. Thirty-one infants were enroled, three without informative sampling, leaving 14 per group. No statistical differences were seen in faecal calprotectin on Day 7 (236 mcg/g PHMF vs. 303 mcg/g PBMF, p = 0.90) or 21 (135 mcg/g PHMF vs. 315 mcg/g PBMF, p = 0.21). Adjusting for gestation and day of life, and including all time points after enrolment to discharge, fortifier type did not impact faecal calprotectin (coefficient estimate -7.13, 95% confidence interval = -172 to 158, p = 0.93). Rates of key neonatal morbidities did not differ. PHMF infants grew more slowly reaching statistical significance in change in weight standard deviation score at discharge compared to PBMF infants (mean (standard deviation) -0.94 (0.7) PHMF vs. -0.24 (0.8) PBMF, p = 0.02).
We did not detect reduced gut inflammation as measured by faecal calprotectin in PHMF compared to PBMF but weight gain was slower, of potential clinical importance.
比较以人乳为基础的粉状强化剂（PHMF）与以牛乳为基础的粉状强化剂（PBMF）对纯母乳喂养的早产儿粪便钙卫蛋白、血浆氨基酸及临床结局的影响。
对孕周<32周或出生体重<1500g、仅接受母乳且已达到完全肠内喂养（150mL/kg/天）、无既往胃肠道疾病的婴儿进行一项随机对照试验。主要结局为强化开始后21天内的粪便钙卫蛋白；次要结局为出院时的钙卫蛋白、血浆氨基酸及临床结局，包括生长情况和新生儿疾病。
在制造商撤回PHMF后，该试验提前终止。共纳入31例婴儿，3例无有效样本，最终每组14例。第7天（PHMF组236μg/g，PBMF组303μg/g，p=0.90）和第21天（PHMF组135μg/g，PBMF组315μg/g，p=0.21）时，两组粪便钙卫蛋白无统计学差异。校正孕周和日龄，并纳入入组至出院后的所有时间点，强化剂类型对粪便钙卫蛋白无影响（系数估计值-7.13，95%置信区间=-172至158，p=0.93）。关键新生儿疾病发生率无差异。与PBMF组婴儿相比，PHMF组婴儿生长较慢，出院时体重标准差评分变化具有统计学意义（平均值（标准差）：PHMF组-0.94（0.7），PBMF组-0.24（0.8），p=0.02）。
与PBMF相比，我们未检测到PHMF组婴儿粪便钙卫蛋白所测量的肠道炎症减轻，但体重增加较慢，这可能具有潜在的临床意义。
