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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
65
After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Sergio Mauricio Lerma Narvaez
Galveston, Texas, United States
White Blood Cell Count (WBC) (1)
Normal Range approximately 6,000 - 30,000 cell/mm3.
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
White Blood Cell Count (WBC) (1) INFANT BLOOD
Normal Range: 6.000 - 30.000 cell/mm3.
Time frame: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
Normal Range of I/T ratio: \<0.2.
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
Normal Range: \<0.2
Time frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
CRP (C-Reactive Protein)(1)
Normal Range: \< 10,000 ng/mL
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
CRP (C-Reactive Protein)(2) INFANT BLOOD
Normal Range: \<10.000ng/mL
Time frame: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
IL-6 (1)
Normal Range: 0-10.2 pg/ml
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
IL-6 (Interleukin-6) INFANTS BLOOD
Normal Range: \<100 pg/mL
Time frame: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Procalcitonin PUBC
Blood was taken from PUBC after delivery
Time frame: Within 30 minutes after delivery
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Procalcitonin levels
Time frame: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
Normal Range: Blood Culture Negative
Time frame: Blood sample drawn from placenta and from baby within 6 hours after birth.
Presepsin- PUBC
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Time frame: First 30 min after birth
Presepsin-Infant's Blood
Levels of presepsin
Time frame: First 30 min after birth
Number of Participants With a Negative Blood Culture
Blood is taken from infants after birth
Time frame: first 2 hours after birth
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