Department of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Ital J Pediatr. 2018 Aug 16;44(1):96. doi: 10.1186/s13052-018-0532-7.
Human milk (HM) is the best feeding for premature infants. When own mother's milk (OMM) is insufficient or unavailable, pasteurized donor human milk (PDHM) and preterm formula (PF) are the alternative nutritional sources, but the benefits of donor milk over formula are not defined. This study aimed to assess whether, in the absence of OMM, the PF could guarantee a feeding tolerance not inferior to that seen with the use of PDHM during the first two weeks of life of very preterm infants.
Infants with gestational age (GA) of ≤32 weeks who started enteral feeding within the first 7 days of life were randomized to receive PDHM or PF as a supplement to the OMM insufficient or unavailable. The primary outcome was the day of life when full enteral feeding (FEF) of 150 mL/Kg/d was achieved.
Seventy infants were randomized, 35 in the PF group (GA 30.2 ± 1.7 weeks; BW 1342 ± 275 g), 35 in the PDHM group (GA 30 ± 1.9 weeks; BW 1365 ± 332 g). The time to achieve FEF was the same for infants fed with PF and for infants fed with PDHM (12.3 ± 7.0 days vs 12.8 ± 6.5).
This trial shows that PF could be a valid alternative for the early feeding of very preterm infants when OMM is insufficient or unavailable.
UMIN000013922 . Date of formal registration: December 31, 2014.
母乳是早产儿最好的喂养方式。当母亲的母乳不足或无法提供时，巴氏消毒的捐赠人乳（PDHM）和早产儿配方（PF）是替代营养来源，但捐赠奶相对于配方的益处尚未确定。本研究旨在评估在没有 OM 的情况下，PF 是否能保证在出生后前两周的非常早产儿的喂养耐受性不低于使用 PDHM。
出生胎龄（GA）≤32 周的婴儿，在出生后 7 天内开始进行肠内喂养，随机分为接受 PDHM 或 PF 作为 OM 不足或无法提供的补充。主要结局是达到每天 150 毫升/公斤/天的完全肠内喂养（FEF）的天数。
70 名婴儿被随机分配到 PF 组（GA 30.2±1.7 周；BW 1342±275 克）和 PDHM 组（GA 30±1.9 周；BW 1365±332 克）。用 PF 喂养的婴儿和用 PDHM 喂养的婴儿达到 FEF 的时间相同（12.3±7.0 天与 12.8±6.5 天）。
本试验表明，当 OM 不足或无法提供时，PF 可作为早期喂养非常早产儿的有效替代物。
UMIN000013922。正式注册日期：2014 年 12 月 31 日。
