Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord

Intervention / Treatment
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* Other: Placental/Umbilical Cord Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants <34 weeks' gestational Exclusion Criteria: Known congenital or chromosomal anomalies Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect) Vaginal bleeding at admission

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placental/Umbilical Cord Blood sample<br>Placental/Umbilical Cord Blood sample will be collected after delivery from every participant. | Other: Placental/Umbilical Cord Blood sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Blood Cell Count (WBC) (1) | Normal Range approximately 6,000 - 30,000 cell/mm3. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | First 30 min after birth | 
| Presepsin-Infant's Blood | Levels of presepsin | First 30 min after birth | 
| Number of Participants With a Negative Blood Culture | Blood is taken from infants after birth | first 2 hours after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture