Predictors of Sepsis in Ex-Preterm Infants
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Boston Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria Ex-Preterm Infant Group:
- Infants born less than 37 weeks gestational age
Exclusion Criteria for Ex-Preterm Infant Group:
- Infants born greater than 37 weeks gestational age
Inclusion Criteria for Term Infant Group:
- Infants born greater than 37 weeks gestational age
Exclusion Criteria for Term Infant Group:
- Infants born less than 37 weeks gestational age
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Preterm Infants
Blood samples will be obtained from preterm and former preterm infants at birth and then monthly until hospital discharge.
The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen.
If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
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Term Infants
Blood samples will be obtained from term control infants admitted to the NICU monthly until hospital discharge.
The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen.
If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.
大体时间：Up to 1 year
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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.
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Up to 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization.
大体时间：Up to 1 year
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The investigators will measure nutritional status.
Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.
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Up to 1 year
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合作者和调查者
调查人员
- 首席研究员：Amy O'Connell, MD、Boston Children's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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