Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- vaccination reaction
研究概览
简要总结
Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.
详细描述
The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born at University Hospital Tübingen
- •at least one dose of antibiotics within the first week of life
排除标准
- •genetic disorders
- •chronic infections
- •hematological disorders
- •immunoglobulins within the first 60 days of life
- •immunological disorders
- •infants from Hepatitis B positive mothers
研究组 & 干预措施
ABT in the first week of life
VLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life
干预措施: ABT (Drug)
结局指标
主要结局
vaccination reaction
时间窗: 7 months
measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months)
次要结局
- Microbiome composition(7 months)
研究者
Dr. Natascha Köstlin-Gille
Junior Research Group Leader
University Hospital Tuebingen