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

Not Applicable

Completed

Conditions: Preterm Infant
Umbilical Cord
Early-Onset Neonatal Sepsis

Interventions: Other: Placental/Umbilical Cord Blood sample

Registration Number: NCT03694613

Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placental/Umbilical Cord Blood sample	Placental/Umbilical Cord Blood sample	Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.

Primary Outcome Measures

Name	Time	Method
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count	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)	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	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)	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	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)	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	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	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	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	Blood sample drawn from placenta and from baby within 6 hours after birth.	Normal Range: Blood Culture Negative
IL-6 (Interleukin-6) INFANTS BLOOD	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	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	First 30 min after birth	Levels of presepsin
Number of Participants With a Negative Blood Culture	first 2 hours after birth	Blood is taken from infants after birth