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临床试验/NCT00524394
NCT00524394终止不适用

Characteristics of Cord Blood Immunologic Parameters of Infants < 32 Weeks Gestation

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Immunological Homeostasis

研究概览

简要总结

Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and regulatory proteins (cytokines & chemokines, in addition to antigen detection on antibody secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of infections in these high-risk patients.

详细描述

Sampling methods/Data collection

Samples: Serum (1-2ml) from enrolled infants will be collected from cord blood (T0). Serial samples (0.5-1ml) will be collected at 3 other times: T1= 4-7 days, T2=10-14 days, T3= 20-30 days. These can be drawn at initiation of any sepsis work-up, or prior to any transfusion of PRBC's or when any blood ≥0.5ml will be wasted. These collections are intended to analyze the immunologic milieu in infants at various stages of natal and post-natal immune adaptation:

  1. baseline levels from a relatively privileged environment (cord blood T0)
  2. peak of immunogenic response after prenatal exposure (T1)
  3. plateau of immunogenic response after perinatal exposure (T2)
  4. relative state of equilibrium with surrounding flora (T3)

Data collection:

Baseline statistics at enrollment: Birth weight, obstetrical assessment of gestational age, mode of delivery, presence of labor, presence of IAI, ROM, intrapartum antibiotics type and length, With each sampling, data will be gathered via chart review on each infant. We will also gather data at 60 DOL, discharge, or death on any infant enrolled.

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
— 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born at Children's Memorial Hermann Hospital with cord blood available < 1500gm or < 32 weeks gestation by OB estimate

排除标准

  • Outborn infants transferred to CMHH without cord blood available
  • Parents to not consent
  • > 1500gm or > 32 weeks gestation by OB estimate

结局指标

主要结局

Immunological Homeostasis

时间窗: 0 to 30 days of life.

Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages

Cytokines

时间窗: O TO 30 DAYS OF LIFE

IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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