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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants <34 weeks' gestational
排除标准
- •Known congenital or chromosomal anomalies
- •Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)
- •Vaginal bleeding at admission
结局指标
主要结局
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
时间窗: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range of I/T ratio: \<0.2.
CRP (C-Reactive Protein)(1)
时间窗: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Normal Range: \< 10,000 ng/mL
CRP (C-Reactive Protein)(2) INFANT BLOOD
时间窗: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
Normal Range: \<10.000ng/mL
White Blood Cell Count (WBC) (1)
时间窗: 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.
White Blood Cell Count (WBC) (1) INFANT BLOOD
时间窗: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
Normal Range: 6.000 - 30.000 cell/mm3.
IL-6 (1)
时间窗: 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
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
时间窗: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
Procalcitonin levels
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
时间窗: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Normal Range: \<0.2
Procalcitonin PUBC
时间窗: Within 30 minutes after delivery
Blood was taken from PUBC after delivery
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
时间窗: Blood sample drawn from placenta and from baby within 6 hours after birth.
Normal Range: Blood Culture Negative
IL-6 (Interleukin-6) INFANTS BLOOD
时间窗: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Normal Range: \<100 pg/mL
Presepsin- PUBC
时间窗: First 30 min after birth
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Presepsin-Infant's Blood
时间窗: First 30 min after birth
Levels of presepsin
Number of Participants With a Negative Blood Culture
时间窗: first 2 hours after birth
Blood is taken from infants after birth
次要结局
未报告次要终点