Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Number of participants with CMV viruria
研究概览
简要总结
To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.
The protocol has been approved by the ethics committee of Tuebingen University Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
入排标准
- 年龄范围
- 23 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<32 Weeks or GA or <1500g BW
- •mother CMV IgG positive
- •breast milk feeding
排除标准
- •parents disagree
研究组 & 干预措施
Mother CMV positive
干预措施: ultrashort heat inactivation (Procedure)
结局指标
主要结局
Number of participants with CMV viruria
时间窗: 40 weeks gestational age, or at discharge from NICU (if this is earlier)
次要结局
- Number of participants with specific neonatal outcome parameters as a measure of neonatal quality(40 weeks of gestational age or at discharge from NICU (if this is earlier))