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临床试验/NCT02477423
NCT02477423已完成不适用

A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

University of Chicago1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Shannon Diversity of the Preterm Infant Microbiome

研究概览

简要总结

The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
— 至 6 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Randomized & Blinded - Receiving Antibiotics

Active Comparator

The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.

干预措施: Ampicillin (Drug)

Randomized & Blinded - Receiving Antibiotics

Active Comparator

The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.

干预措施: Gentamicins (Drug)

Randomized & Blinded - Receiving Placebo

Placebo Comparator

The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.

干预措施: Placebo (Drug)

结局指标

主要结局

Shannon Diversity of the Preterm Infant Microbiome

时间窗: 2 weeks

Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.

Richness of the Preterm Infant Microbiome

时间窗: 2 weeks

Number of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) detected in each sample. A higher richness means that a higher number of species of archaea and bacteria was detected in a sample.

次要结局

  • Chronic Lung Disease of Infancy (CLD)(4-12 weeks)
  • Intraventricular Hemorrhage (IVH)(4-12 weeks)
  • Death(18 months)
  • Necrotizing Enterocolitis (NEC)(4-12 weeks)
  • Retinopathy of Prematurity (ROP)(4-12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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