Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Analyses of b- and t-cells development
研究概览
简要总结
Since the neonatal sepsis is still one of the most common causes of death in preterm infants up to 80% receive an perinatal antibiotic treatment. It is also known that an antibiotic treatment is one of the most important influences for the establishment of the intestinal microbiome. This again is important for the development of an healthy neonatal immunosystem. A pilot study showed that an antibiotic therapy in the first week of life had a negative influence on the vaccine titers of preterm infants.
In this study it will be further investigated if an early antibiotic treatment influences the development of the adaptive immunosystem in preterm infants and if this antibiotic treatment effects the development of the intestinal microbiome.
详细描述
The study wants to investigate the impact of the antibiotic treatment in the first week of live on the adaptive immunosystem. For this the antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus influenzae B, Tetanus, Diphtheria and Pneumococcus of very low birth weight infants (VLBWI) who receive an early antibiotic therapy will be compared with the antibody titers of infants who did not receive antibiotic treatment. Further the development of b- and t-cells will be tested.
To show the modulation of the intestinal microbiome through antibiotics stool samples of VLBWI with and without antibiotic therapy in first week of life will be tested for their composition and diversity as well as for the production of short-chained fatty acids (SCFA) In this study 82 VLBWI (42 per group) will be included. Infants will be matched by 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 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born at University Hospital Tübingen
- •received at least one dose of antibiotics during the first week of life
排除标准
- •genetic disorders
- •chronic infections
- •hematological disorders
- •treatment with immunoglobulins during the first 60 days of life
- •immunological disorders
- •infants with 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 31+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
Analyses of b- and t-cells development
时间窗: 7 Month
Analyses of b- and t-cell development with the adjusted age of 4 moth
Vaccination response
时间窗: 7 Month
Measurement of antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus Influenzae B, Tetanus, Diphteria and Pneumococcus four month after the first received vaccination
次要结局
- Analyses of SCFA production of the intestinal microbiome(7 month)
- Microbiome analyses(7 Month)