Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
赞助:
The University of Texas Medical Branch, Galveston
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
White Blood Cell Count (WBC) (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range approximately 6.000 - 30.000 cell/mm3. I/T ratio (Immature/Total immature neutrophil)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range: <0.16 ANC (Absolute Neutrophil Count) (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range:500-6000 Cells/mm3 CRP (C-Reactive Protein)(1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range: 0.01-0.64mg/dl IL-6 (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range: 0-10.2 pg/ml Blood culture (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ] Normal Range: NEGATIVE White Blood Cell Count (WBC) (1)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range: 6.000 - 30.000 cell/mm3. I/T ratio (Immature/Total immature neutrophil)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range: <0.16 ANC (Absolute Neutrophil Count) (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range:500-6000 Cells/mm3 CRP (C-Reactive Protein)(2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range: 0.01-0.64mg/dl IL-6 (Interleukin-6) (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range: 0-10.2 pg/ml Blood Culture (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ] Normal Range: Negative |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants | ||
| 正式标题 ICMJE | A Pilot Study to Evaluate the Utility of Placental/Umbilical Cord Blood (PUCB) in Early Onset Neonatal Sepsis (EONS) in Very Low Birth Weight Infants | ||
| 简要概况 | This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth). |
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| 详细说明 | Early Onset Neonatal Sepsis (EONS) is common in preterm infants, and it is associated with high morbidity and mortality, especially if not diagnosed early. Currently the baseline workup is done using blood samples from the infant to perform Blood culture, CBC, I/T ratio. These tests have shown to have low sensitivity and specificity to diagnosis EONS. PUCB can be another safe source of blood which is useful, painless and simple to collect. As CBC, I/T ratio and blood culture may not be enough to diagnose EONS we will add IL-6 and CRP which will increase sensitivity and specificity to diagnose EONS in preterm infants without collecting blood from the infants. This study may be a step to decrease iatrogenic blood loss to diagnose EONS. The primary outcome of the current research will be to find out the utility of PUCB in diagnosing EOS in preterm infants (<30 weeks and <1250 grams birth weight). Using PUCB can increase the accuracy to diagnose Sepsis in Preterm infants, and it will also conserve blood in the extremely premature infants while reducing hemodynamic instability due to acute blood loss. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述:Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results 主要目的: Diagnostic |
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| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
63 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2020 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Infants <30 weeks' gestational and <1250 grams birth weight Exclusion Criteria: - Known congenital or chromosomal anomalies - Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect) - Multiple pregnancy - Vaginal bleeding at admission | ||
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| 年龄 | 最小年龄：N/A ，最大年龄：1 Day | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | The University of Texas Medical Branch, Galveston | ||
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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