Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Instituto de Medicina Tropical "Alexander von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX.
Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.
J Pediatr. 2020 Apr;219:118-125.e5. doi: 10.1016/j.jpeds.2019.12.038. Epub 2020 Feb 6.
To determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay.
Randomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age.
Of the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
Supplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects.
ClinicalTrials.gov: NCT01525316.
确定牛乳铁蛋白对预防晚发性败血症（LOS）和神经发育迟缓的影响。
在秘鲁利马的 3 个新生儿单位中，对出生体重为 500-2000g 的新生儿进行了一项随机、双盲、对照试验，比较了每天 200mg/kg 的牛乳铁蛋白与安慰剂治疗 8 周。主要结局是首次培养证实的 LOS 或与败血症相关的死亡。神经发育迟缓在 24 个月校正年龄时通过门氏量表进行评估。
在纳入的 414 名婴儿中，209 名接受了牛乳铁蛋白治疗，205 名接受了安慰剂治疗。牛乳铁蛋白组中有 22 名（10.5%）婴儿发生 LOS 或与败血症相关的死亡，安慰剂组中有 30 名（14.6%）婴儿发生；在校正医院和出生体重后无差异；风险比为 0.73（95%CI，0.42-1.26）。对于出生体重<1500g 的婴儿，风险比为 0.69（95%CI，0.39-1.25）。在 24 个月时，牛乳铁蛋白组的年龄调整后平均正常化门氏综合评分（mean age-adjusted normalized Mullen composite score）为 83.3±13.6，安慰剂组为 82.6±13.1。在 2 年的随访期间，两组的生长结果和再住院率相似，除了牛乳铁蛋白组的细支气管炎发生率显著降低（发生率比，0.34；95%CI，0.14-0.86）。
补充牛乳铁蛋白并不能降低出生体重<2000g 的婴儿败血症的发生率。24 个月时的生长和神经发育结果相似。新生儿牛乳铁蛋白补充剂没有不良影响。
ClinicalTrials.gov：NCT01525316。
