初乳经口咽免疫疗法用于极低出生体重早产儿：一项干预性研究方案
Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study.
作者信息
da Cruz Martins Camilla, de Santana Xavier Ramos Michelle, Viana Cardoso Amaral Mara, Santos Passos Costa Jéssica, Souza Cerqueira Ellayne, de Oliveira Vieira Tatiana, dA Cruz Simone Seixas, Oliveira Vieira Graciete
机构信息
State University of Feira de Santana, Av. Transnordestina, s/n - Novo Horizonte, CEP: 44036-900, Feira de Santana, Bahia, Brazil.
Federal University of Recôncavo da Bahia, Santo Antônio de Jesus, Bahia, Brazil.
出版信息
BMC Pediatr. 2020 Aug 7;20(1):371. doi: 10.1186/s12887-020-02266-8.
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.
TRIAL REGISTRATION
ReBEC, U1111-1222-0598 , Registered 09 October 2018, http://www.ensaiosclinicos.gov.br/rg/RBR-2cyp7c/ .
背景
在新生儿健康服务中，采用口咽初乳给药方案治疗早产新生儿是一种可行且合理的策略，因为初乳中的免疫保护成分可被口咽淋巴组织吸收。在此背景下，本研究旨在描述在一家新生儿病房对极低出生体重早产新生儿实施口咽初乳免疫疗法的情况，并在一家公立医院测试一种算法。
方法
该方案应用于一项采用历史对照的非随机优效性临床试验。治疗组中，将0.2毫升生初乳滴入左右口咽黏膜，每24小时共给药8次，直至出生后第7个完整日，期间间断给药。对照组由前几年在同一家医院出生的极低出生体重早产新生儿组成（历史对照）。用标准化表格记录60名新生儿直至出院的临床进展情况。预计4年内共有350名参与者完成该调查。通过配对t检验或威尔科克森两样本检验比较两组间连续结局的发生情况。卡方检验或费舍尔精确检验以及生存分析用于二元结局。通过早产儿的Intergrowth-21st生长曲线评估营养状况。
讨论
该方案行动流程由一种算法进行排序，与巴西公立医院的实际情况相符。这项措施有助于简化和系统化临床护理，组织团队的工作流程，加快干预步骤，规范决策并统一护理质量，此外还显示了口咽初乳免疫疗法的可行性。
试验注册
ReBEC，U1111 - 1222 - 0598，于2018年10月9日注册，http://www.ensaiosclinicos.gov.br/rg/RBR-2cyp7c/ 。
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