目的:探讨生后早期口腔初乳涂抹（oropharyngeal administration of colostrum, OAC）对极低出生体重早产儿的免疫保护作用。方法:采用前瞻性随机安慰剂对照非盲试验方法，纳入2019年1月至12月间在生后24 h内收住福建省妇幼保健院新生儿科的出生体重≤1 500 g且胎龄≤32周的早产儿，随机分为干预组和对照组，在生后48 h内开始分别给予OAC（0.4 ml母乳涂抹口腔，每3小时一次，每天8次）或生理盐水进行口腔护理直至生后10 d。主要结局指标为坏死性小肠结肠炎（necrotizing enterocolitis, NEC）和晚发型败血症（late-onset sepsis, LOS）的发生率。次要结局指标包括达完全肠内喂养日龄、达完全经口喂养日龄、体重增长速率、有创机械通气及无创通气时间、经皮中心静脉置管时间、住院时间以及相关并发症如动脉导管未闭、Ⅲ级及以上脑室内出血、脑室周围白质软化、支气管肺发育不良、早产儿视网膜病变、胆汁淤积症的发生率。不良反应为口腔黏膜破损。采用两独立样本n t检验、非参数秩和检验及n χ2检验进行统计学分析。n 结果:研究期间共收治符合纳入标准的早产儿207例，排除7例，5例退出研究，最终纳入195例，其中对照组97例，干预组98例。（1）主要结局指标：干预组Ⅱ期及以上NEC以及LOS的发生率均低于对照组[3.1%（3/98）与10.3%（10/97），n χ2=4.116，n P=0.042；4.1%（4/98）与13.4%（13/97），n χ2=5.322，n P=0.021]。（2）次要结局指标：干预组达完全肠内喂养日龄较对照组小[22.0 d（16.0~29.0 d）与25.0 d（19.0~40.0 d），n Z=3 814.000，n P=0.017]，Ⅲ级及以上脑室内出血的发生率低于对照组[1.0%（1/98）与7.2%（7/97），Fisher精确概率法，n P=0.035]。2组间其他次要结局指标差异无统计学意义（n P值均>0.05）。（3）干预组内超低出生体重儿与对照组内超低出生体重儿相比，LOS发生率降低（0/13与3/7，n P=0.031），达完全肠内喂养日龄较小[36.0 d（31.0~42.0 d）与46.0 d（42.0~71.0 d），n Z=13.500，n P=0.008]，其他结局指标比较差异均无统计学意义（n P值均>0.05）。（4）2组均未观察到口腔黏膜破损发生。n 结论:极低出生体重早产儿生后早期给予OAC可以降低NEC、LOS和严重脑室内出血的发生率，并缩短达完全肠内喂养的时间，且无明显不良反应。“,”Objective:To evaluate the immunoprotective effects of early oropharyngeal administration of colostrum (OAC) in very low birth weight preterm infants.Methods:This was a prospective, randomized, placebo-controlled, non-blind trial involving very low birth weight preterm infants (birth weight ≤1 500 g and gestational age ≤32 weeks) who were admitted to the Department of Neonatology of Fujian Provincial Maternity and Children's Hospital within 24 h after birth from January to December 2019. These infants were randomly given 0.4 ml maternal colostrum (intervention group) or normal saline (control group) oropharyngeally within 48 h after birth every 3 h for 10 d. Primary outcomes were the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS). Secondary outcomes included the age at full enteral feeding and full oral feeding, the rate of weight gain, the duration of mechanical ventilation and non-invasive ventilator, the indwelling time of peripherally inserted central catheter, the length of hospitalization, and the incidence of related complications such as patent ductus arteriosus, gradeⅢ or more severe intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity and cholestasis. The adverse reaction was oral mucous membrane injury. Two-independent samplen t-test,n Chi-square test and rank-sum test were used for data analysis.n Results:A total of 207 infants, including seven being excluded and five dropping out the study, met the inclusion criteria, and 195 of them were finally enrolled with 98 in the intervention group and 97 in the control group. (1) Primary outcomes: The incidence of NEC (stage Ⅱor more severe) and LOS were both lower in the intervention group than those in the control group [3.1% (3/98) vs 10.3% (10/97), n χ2=4.116, n P=0.042; 4.1% (4/98) vs 13.4% (13/97), n χ2=5.322, n P=0.021]. (2) Secondary outcomes: Full enteral feeding was achieved earlier in the intervention group than in the control group [22.0 d (16.0-29.0 d) vs 25.0 d (19.0-40.0 d), n Z=3 814.000, n P=0.017] and the incidence of gradeⅢ and above intraventricular hemorrhage was lower [1.0% (1/98) vs 7.2% (7/97), Fisher's exact test,n P=0.035]. There were no statistically significant differences between the two groups in the other secondary outcome indicators (all n P>0.05). (3) In extremely low birth weight infants, the incidence of LOS and the time taken to achieve full enteral feeding were lower in the intervention group than in the control group [0/13 vs 3/7,n P=0.031; 36.0 d (31.0-42.0 d) vs 46.0 d (42.0-71.0 d), n Z=13.500, n P=0.008]. There were no statistically significant differences between the two groups in the other indicators (all n P>0.05). (4) No oral mucosal membrane injury was observed in the two groups.n Conclusions:Early OAC can reduce the incidence of NEC (stageⅡ or more severe), LOS and intraventricular hemorrhage (stage Ⅲ or more severe), has beneficial effects on the early achievement of full enteral feeding and no adverse events occurred in very low birth weight preterm infants.