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临床试验/NCT03433846
NCT03433846已完成不适用

Predictors of Sepsis in Ex-Preterm Infants

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.

研究概览

简要总结

The aims of this study are to:

  • Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age.
  • Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.

详细描述

Preterm infants have increased numbers of viral infections in childhood. They are also more likely to die from infection during the neonatal and infant periods than infants born at term. While studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. There have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. Given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy.

The goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. Additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.

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
0 Days 至 2 Years(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

结局指标

主要结局

The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.

时间窗: Up to 1 year

The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.

次要结局

  • Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization.(Up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy O'Connell

MD, PhD

Boston Children's Hospital

研究点 (1)

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Predictors of Sepsis in Ex-Preterm Infants | 临床试验