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

NCT03694613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-08-10

Study results available
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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).

Conditions

  • Preterm Infant
  • Early-Onset Neonatal Sepsis
  • Umbilical Cord

Interventions

OTHER

Placental/Umbilical Cord Blood sample

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.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • sergio M Lerma Narvaez · UTMB, Galveston

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-06-01
Completion
2020-08-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694613 on ClinicalTrials.gov