A longitudinal study tracing the evolution of gut microbiome of preterm neonates and its correlation with sepsis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- 1.Patterned Progression of bacterial population of gut microbiota of preterm neonates and preterm neonates developing a neonatal infection.
研究概览
简要总结
The purpose of this study is to study the colonization pattern of preterm neonates of gestation age <34 weeks,in the first 28 days of life of neonates to determine key insights into the onset of sepsis development, impact, and recovery. Further study aims todetermine the effect of antimicrobial therapy in gut colonization andantimicrobial resistance development.
Scientific Hypothesis:
H1: The association between microbiomeand host: whether the composition of the microbiome or “dysbiotic†microbiomeis linked to neonatal sepsis and antibiotic resistance.
H2: Whether microbiome is associated withbiological covariates, the impact of mode of delivery on the microbiome, influenceof feeding practice in IUGR (Intrauterine growth restriction) preterm with andwithout neonatal sepsis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1 All inborn preterm babies admitted to the Neonatal Intensive Care Unit.
- •2 Gestational age <34 weeks.
- •3 Informed consent from the mother.
- •4 Neonate admitted to NICU for at least 28 days.
排除标准
- •1 Neonate with Surgical/chromosomal abnormalities.
- •2.Neonates with necrotizing enterocolitis 3 Neonates undergoing Gastrointestinal surgeries.
- •4.Culture Negative Sepsis 5 No informed consent is given.
结局指标
主要结局
1.Patterned Progression of bacterial population of gut microbiota of preterm neonates and preterm neonates developing a neonatal infection.
时间窗: 105 weeks
2.Variability of gut microbial patterns due to mode of delivery, Influence of gestational age, antibiotic exposure and feeds in the preterm neonates with and without sepsis.
时间窗: 105 weeks
次要结局
- 1.The gut microbial colonization pattern of preterm infants, in the first 28 days of life of infant to determine key insights into the onset of sepsis development, impact, and recovery.(2.Protective role of gut microbiota in modulating of neonatal sepsis.)