Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study
Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study
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DOI：
10.1186/s12887-020-02266-8
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发表时间：
2020-08-07
期刊：
影响因子：
2.4
通讯作者：
Vieira, Graciete Oliveira
中科院分区：
文献类型：
--
作者：
Martins, Camilla da Cruz;Xavier Ramos, Michelle de Santana;Vieira, Graciete Oliveira
背景口咽初乳给药方案用于治疗早产儿是新生儿保健服务中一种可能且看似合理的策略，因为初乳的免疫保护成分可被口咽淋巴组织吸收。在此背景下，本研究旨在描述口咽初乳免疫疗法在新生儿病房极低出生体重早产儿中的实施情况，并在公立医院测试算法。方法将该方案应用于具有历史对照的非随机、优势临床试验。治疗组左、右侧口咽粘膜分别滴入生初乳0.2m L，每24 h给药8次，连续给药至生后第7天。对照组为往年在同一医院出生的极低出生体重早产儿(历史对照)。60例新生儿出院前的临床进展记录在标准化表格上。预计共有350名参与者将在4年内完成调查。两组间连续结局的发生情况通过配对t检验或Wilcoxon的两样本检验进行比较。二项结果采用卡方检验或Fisher‘s精确检验和生存分析。通过共生生长-21生长曲线评价早产儿的营养状况。讨论该协议的操作流程由一种算法进行分类，与巴西公立医院的实际情况相兼容。这一措施除了表明口咽初乳免疫疗法的可行性外，还促进了临床护理的便利化和系统化，组织了团队的工作流程，加快了干预步骤，规范了决策，统一了护理质量。
Background The oropharyngeal colostrum administration protocol to treat premature newborns is a possible and plausible strategy in neonatal health services, since the immunoprotective components of colostrum can be absorbed by the lymphoid tissues of the oropharynx. In this context, this study aims to describe the implementation of oropharyngeal colostrum immunotherapy in very low birth weight preterm newborns in a neonatal unit, as well as to test an algorithm in a public hospital. Methods The protocol is applied in a non-randomized, superiority clinical trial with historical control. In the treatment group, 0.2 mL of raw colostrum is dripped into the right and left oropharyngeal mucosa, totaling 8 administrations every 24 h until the 7th complete day of life interruptedly. The control group consists of very low birth weight preterm newborns born in the same hospital in previous years (historical control). The clinical progression of 60 newborns until hospital discharge is recorded on standardized forms. A total of 350 participants are estimated to complete the survey in 4 years. The occurrence of continuous outcomes between the groups are compared through the paired t-test or Wilcoxon's two-sample test. The chi-square test or Fisher's exact test, and survival analysis are used for binary outcomes. The nutritional status is assessed through Intergrowth-21st growth curves for preterm newborns. Discussion The flows of the protocol's actions is sorted by an algorithm, compatible with the Brazilian reality of a public hospital. This measure facilitates and systematizes clinical care, organizes the team's work process, speeds up the intervention steps, standardizes decision-making and unifies the quality of care, besides showing the feasibility of oropharyngeal colostrum immunotherapy.