Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 437
- 主要终点
- Identify probiotic strains that may decrease the incidence of atopic dermatitis.
研究概览
简要总结
The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.
详细描述
In this study, the investigators analyse the influence of nutrition during the early neonatal period on the development and prevention of atopic dermatitis (AD) in children with a history of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm infants to assess the risk of their developing AD during childhood, according to nutrition with breastmilk and/or probiotic supplementation during the neonatal period. The analysis focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184 received probiotics up to 36 weeks postmenstrual age.
The neonatal history of the patients was consulted in their electronic medical records (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual age; nutricional management; administration of probiotics), and the presence of atopic diseases at school age was corroborated by telephone interviews.
The descriptive date were summarized using medians and interquartile intervals for the continuous variables and distribution frequencies for the categorial variables. Univariate comparisons were made by the Mann-Whitney test for the continuous variables and by the chi-square test for the categorical variables. The association of comorbidities in VLBW newborns and supplementation with one type or another of probiotic was evaluated with a multinomial regression analysis, ajustando por las variables que mostraron diferencias en el análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS 20.0 for Windows software
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn with a gestational age < or = 32 weeks and/or birth weight < or = 1500 grams.
排除标准
- •Incomplete health history record o lack of data.
- •Severe congenital anomalies.
结局指标
主要结局
Identify probiotic strains that may decrease the incidence of atopic dermatitis.
时间窗: From birth to January 2023
In the group of patients who received probiotics we found two groups, one group received Lacticaseibacillus rhamnosus ATCC 53103 and the other group received the combination of Lactobacillus acidophilus ATCC 4356 + Bifidobacterium bifidum ATCC 15696. An attempt will be made to identify if there are differences between them.
Change incidence of atopic dermatitis in children receiving probiotics
时间窗: From birth to January 2023
The investigators will assess the presence of atopic dermatitis (itching and chronic or recurrent eczematous lesions with typical morphology and distribution) in the telephone interview.
To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children.
时间窗: From birth to January 2023
The investigators will ask patients for both attopic dermatitis involvement and a history of probiotic and breast milk administration in the neonatal period.
Influence of caloric intake on the development of atopic dermatitis
时间窗: From birth to January 2023
The researchers will look at the medical history for caloric and macronutrient intake during the first weeks of life and assess whether it is related to differences in the development of atopic dermatitis.
次要结局
未报告次要终点
研究者
José Uberos Fernández
Head of Unit Care Neonatology, Principal Investigator, Clinical Professor
Hospital Clinico Universitario San Cecilio