Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- qRT-PCR (polymerase chain reaction) quantitative stool analysis
研究概览
简要总结
This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.
详细描述
Necrotizing enterocolitis (NEC) is a leading cause of death in preterm infants, yet the disease mechanism is not well understood. Among the factors that have been studied are the change in stool microbiota (dysbiosis), severe anemia, and transfusion. Studies suggest that dysbiosis occurs in neonates with NEC. Large studies and meta-analyses have shown a predominance of Gammaproteobacteria, a decrease in Firmicutes, and decreased bacterial diversity in stool from infants with NEC. Studies do not support a relationship between transfusions and NEC since there are conflicting findings on this topic. There is a suggestion, however, that severe anemia may be associated with NEC though this requires further study.
No studies have been done evaluating the relationship between anemia and change in stool microbiota, or blood transfusion and change in stool microbiota. This study aims to primarily evaluate the relationship between anemia and stool microbiota, and secondarily evaluate the relationship between transfusion and stool microbiota.
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
- 7 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants less than 32 weeks gestation at birth
- •Age at enrollment between 7 days and less than/equal to 30 days
- •Minimum 100 mL/kg/day enteral feeds
排除标准
- •Development of necrotizing enterocolitis (NEC) prior to enrollment
- •Prior surgery
- •Major congenital anomalies
- •Oxygen requirement with FiO2 (fraction of inspired oxygen) >50% (at time of enrollment)
结局指标
主要结局
qRT-PCR (polymerase chain reaction) quantitative stool analysis
时间窗: qRT-PCR will be analyzed for infant stool samples from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant.
Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples
次要结局
- Alpha diversity(Infant stool samples will be analyzed from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant.)
研究者
Julie Mirpuri Hathiramani
Assistant Professor of Medicine
University of Texas Southwestern Medical Center