Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.
研究概览
简要总结
The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.
详细描述
For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:
Mother: Venous blood sample taken at birth (+/- three days)
Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.
The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.
排除标准
- •Newborns of underage mothers.
- •Newborns whose mother did not sign the written informed consent.
- •Pregnant women with a known hereditary or acquired immune deficiency
结局指标
主要结局
To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.
时间窗: Newborn: immediately after birth; Mother +/- 3 days at birth
Measurement of HCMV and VZV-antibodies in the fetal and the maternal circulation
次要结局
- Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.(Newborn: immediately after birth; Mother +/- 3 days at birth)
研究者
Dr. med. Horst Buxmann
Principal Investigator
Johann Wolfgang Goethe University Hospital