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

The University of Texas System (UT)

Status: Completed

Conditions: Preterm Infant; Early-Onset Neonatal Sepsis; Umbilical Cord

Treatments: Other: Placental/Umbilical Cord Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03694613

18-0165

Details and patient eligibility

About

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).

Full 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.

Enrollment: 65 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Placental/Umbilical Cord Blood sample

Other group

Description:

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

Treatment:

Other: Placental/Umbilical Cord Blood sample