Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 583
- 试验地点
- 2
- 主要终点
- Incidence of necrotizing enterocolitis and all-cause mortality
研究概览
简要总结
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
- •Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.
排除标准
- •Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
- •Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
- •Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
结局指标
主要结局
Incidence of necrotizing enterocolitis and all-cause mortality
时间窗: From birth until three months
The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.
次要结局
- Incidence of Bronchopulmonary Dysplasia(From birth until three months)
- Incidence of patent ductus arteriosus(From birth until three months)
- Intestinal colonization by administered strains(From birth until three months)
- Days of Central Vascular Catheter(From birth until three months)
- Time to complete enteral nutrition(From birth until three months)
- Incidence of Late Onset Sepsis(From birth until three months)
- Length of hospital stay(From birth until three months)
- Weight change(From birth until three months)
研究者
José Antonio Hurtado Suazo
Head of Neonatolgy Division. University Hospital Virgen de las Nieves
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental