Characteristics of Cord Blood Immunologic Parameters of Infants < 32 Weeks Gestation
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:
- baseline levels from a relatively privileged environment (cord blood T0)
- peak of immunogenic response after prenatal exposure (T1)
- plateau of immunogenic response after perinatal exposure (T2)
- 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
- 否
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
