Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vertical Transmission
研究概览
简要总结
The investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric prospective cohort study designed and destined only in Turkey. The investigators are planning to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total number may change according to the prevalence of Covid-19 in neonates.
The investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG values from the neonates.
详细描述
The patients will be recruited by a secure database of "Trials Network" with individualized accounts. Plexus Corporation will hold data monitoring and primary analysis.
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
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born to mothers with Covid-19 infection
排除标准
- •If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.
结局指标
主要结局
Vertical Transmission
时间窗: First 28 days of life
Vertical transmission will be investigated by obtaining neonatal PCR samples in blood, stool and mother milk as well as Neonatal Covid-19 Ig M and Ig G values
次要结局
- Hospital stay(First 28 days of life)
- Early neonatal sepsis rate(First 3 days)
研究者
Mehmet Kenan Kanburoglu
Associate Professor of Pediatrics, Neonatologist, Head of Pediatrics
Recep Tayyip Erdogan University Training and Research Hospital