Department of Pediatrics, NorthShore University HealthSystem, Evanston, IL, USA.
University of Chicago Pritzker School of Medicine, Chicago, IL, USA.
J Perinatol. 2023 May;43(5):601-607. doi: 10.1038/s41372-022-01589-x. Epub 2023 Jan 3.
To determine if oropharyngeal therapy with mother's own milk (OPT-MOM) reduces late-onset sepsis (L-OS; primary outcome), NEC, death, length of stay, time to full enteral nutrition (FEN) and full oral feeds in preterm infants (BW < 1250 g).
Infants (N = 220) were randomized to Group A (milk) or B (placebo) and received 0.2 mL every 2 h for 48 h, then every 3 h until 32 weeks CGA.
There were no significant differences in L-OS, NEC or death. Group A trended towards an 8-day reduction in stay, 8-day reduction in time to FEN and a 6-day reduction in time to full oral feeds, compared to B. While clinically relevant, due to large variability in outcomes and lack of power, p values were > 0.05.
OPT-MOM did not reduce L-OS, NEC or death. Group A trended towards a reduced stay and better nutritional outcomes, but results were not statistically significant.
GOV: NCT02116699.
确定口腔治疗母亲自己的奶(OPT-MOM)是否减少晚发性败血症(L-OS;主要结局)、NEC、死亡、住院时间、完全肠内营养(FEN)时间和早产儿(BW<1250g)完全口服喂养。
将 220 名婴儿随机分为 A 组(奶)或 B 组(安慰剂),并在 48 小时内每 2 小时接受 0.2 毫升,然后每 3 小时接受 32 周 CGA。
L-OS、NEC 或死亡无显著差异。与 B 组相比,A 组的住院时间减少 8 天,FEN 时间减少 8 天,完全口服喂养时间减少 6 天。虽然临床相关,但由于结果的变异性大且缺乏动力,p 值>0.05。
OPT-MOM 并未减少 L-OS、NEC 或死亡。A 组的住院时间和营养结局有改善趋势,但结果无统计学意义。
GOV:NCT02116699。