经口咽给予孕周≤32周早产儿初乳对免疫反应及新生儿发病率的影响：一项双盲随机临床试验
Effect of Oropharyngeal Administration of Colostrum in Premature Newborns ≤32 Weeks of Gestation on the Immune Response and Neonatal Morbidity: A Double-Blind Randomized Clinical Trial.
作者信息
Romero-Maldonado Silvia, Soriano-Becerril Diana Mercedes, García-May Perla Karina, Reyes-Muñoz Enrique, Muñoz-Ortíz Eudoxia Georgina, Carrera-Muiños Sandra, Granados-Cepeda Martha Lucía, Cardona-Pérez Jorge Arturo, Castro-Millán Elsa, Segura-Cervantes Enrique, Ceballos Guillermo, Montoya-Estrada Araceli
机构信息
Coordination of the Human Milk Bank, National Institute of Perinatology, Mexico City, Mexico.
Immunology Department, National Institute of Perinatology, Mexico City, Mexico.
出版信息
Front Pediatr. 2022 Jul 8;10:891491. doi: 10.3389/fped.2022.891491. eCollection 2022.
INTRODUCTION
The mother's colostrum carries immunological components, such as cytokines and immunoglobulins (Igs), derived from the maternal circulation with bacteriostatic properties.
OBJECTIVE
The objective of this study was to evaluate the effect of oropharyngeal administration of colostrum (OPAC) vs. placebo in the first 4 days of life in premature newborns ≤32 weeks of gestation on serum Ig concentration, neonatal morbidity, and total days of hospitalization.
HYPOTHESIS
The OPAC increases serum Igs and decreases morbidity and total days of hospitalization.
MATERIALS AND METHODS
A double-blind randomized controlled trial was carried out. Participants were randomly assigned to one of the two groups, namely, group 1: placebo (P) ( = 50) and group 2: colostrum (C) ( = 46). A blood sample was obtained at baseline and 7 and 28 days of life to quantify immunoglobulin G (IgG), immunoglobulin A (IgA), and IgM. Results: The C group showed an increase in serum IgA on day 28 expressed as median and [interquartile range]; C: 25 [12-35] vs. P: 11 [8-18], < 0.001. There were no significant differences in neonatal morbidity. Newborns in the colostrum group showed the completed enteral feeding earlier (days), C: 13.9 ± 7 vs. P: 17.4 ± 8.4, < 0.04; they reached the birth weight earlier, C: 10.9 ± 2.8 vs. P: 12.9 ± 4, < 0.01, and had less days of hospitalization, C: 60.2 ± 33.8 vs. P: 77.2 ± 47.3, < 0.04. Neonatal mortality was lower in the colostrum grou than the placebo group 0% vs. 12%, respectively, without a statistical difference ( = 0.06).
CONCLUSION
In premature newborns ≤32 weeks of gestation, the OPAC within 4 days after birth increases serum IgA concentration at day 28 compared to placebo. Similarly, OPAC decreased the days to complete enteral feeding and reach the birth weight and total days of hospitalization.
CLINICAL TRIAL REGISTRATION
[https://clinicaltrials.gov/ct2/show/NCT03578341], identifier: [NCT03578341].
引言
母亲的初乳含有免疫成分，如细胞因子和免疫球蛋白（Ig），这些成分来自母体循环，具有抑菌特性。
目的
本研究的目的是评估对胎龄≤32周的早产儿在出生后前4天经口咽给予初乳（OPAC）与安慰剂相比，对血清Ig浓度、新生儿发病率和住院总天数的影响。
假设
OPAC可提高血清Ig水平，降低发病率和住院总天数。
材料与方法
进行了一项双盲随机对照试验。参与者被随机分配到两组之一，即第1组：安慰剂（P）组（n = 50）和第2组：初乳（C）组（n = 46）。在出生时、出生后7天和28天采集血样，以定量免疫球蛋白G（IgG）、免疫球蛋白A（IgA）和IgM。结果：C组在第28天时血清IgA以中位数和[四分位间距]表示有所增加；C组：25[12 - 35]，而P组：11[8 - 18]，P < 0.001。新生儿发病率无显著差异。初乳组新生儿更早完成经口喂养（天数），C组：13.9 ± 7，而P组：17.4 ± 8.4，P < 0.04；他们更早达到出生体重，C组：10.9 ± 2.8，而P组：12.9 ± 4，P < 0.01，且住院天数更少，C组：60.2 ± 33.8，而P组：77.2 ± 47.3，P < 0.04。初乳组新生儿死亡率低于安慰剂组，分别为0%和12%，但无统计学差异（P = 0.06）。
结论
对于胎龄≤32周的早产儿，出生后4天内进行OPAC与安慰剂相比，在第28天时可提高血清IgA浓度。同样，OPAC减少了完成经口喂养和达到出生体重的天数以及住院总天数。
临床试验注册
[https://clinicaltrials.gov/ct2/show/NCT03578341]，标识符：[NCT03578341]。
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