Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment: a Randomized, Multicentric, Blinded, Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age.
After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags.
Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors.
Participant files will be stored for a period of 10 years after completion of the study.
All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.
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 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* o Newborns with gestational age \>/= 35 weeks and birth weight \>/= 1800 grams
- •o Intrapartum asphyxia defined according at least one of the following:
- •* APGAR index at 10 minutes \/= 12 mmol/l on arterial blood gas (ABG) analysis within the first 60 minutes of life
- •* Moderate/severe Hypoxic-ischemic encephalopathy assessed between 30 and 60 minutes of life according to Sarnat \& Sarnat definition
- •* Hypothermic treatment. According to the Italian national guidelines on Perinatal Asphyxia and Therapeutic Hypothermia, the hypothermic therapy will be started in the first six hours of life and will last 72 hours.
排除标准
- •Inability to obtain the informed consent from both parents
- •Congenital major malformations or syndromes o Surgical diseases
研究组 & 干预措施
Probiotic group
干预措施: Probiotic mixture (Dietary Supplement)
Placebo group
干预措施: Placebo (Other)
结局指标
主要结局
Morbidity
时间窗: 18 months
Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Mortality
时间窗: 18 months
Death
次要结局
未报告次要终点
研究者
Prof. Maria Elisabetta Baldassarre
Principal Investigator
Policlinico Hospital