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

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

Sponsors

Lead Sponsor: The University of Texas Medical Branch, Galveston

Source 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.

Overall Status Unknown status
Start Date April 1, 2019
Completion Date June 2020
Primary Completion Date April 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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.
I/T ratio (Immature/Total immature neutrophil) Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
ANC (Absolute Neutrophil Count) (1) 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)(1) Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
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.
Blood culture (1) 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) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
I/T ratio (Immature/Total immature neutrophil) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
ANC (Absolute Neutrophil Count) (2) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
CRP (C-Reactive Protein)(2) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
IL-6 (Interleukin-6) (2) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Blood Culture (2) Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Enrollment 63
Condition
Intervention

Intervention Type: Other

Intervention Name: Plancental/Umbilical Cord Blood sample

Description: 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.

Arm Group Label: Placental/Umbilical Cord Blood sample

Eligibility

Criteria:

Inclusion Criteria:

- Infants <30 weeks' gestational and <1250 grams birth weight

Exclusion Criteria:

- Known congenital or chromosomal anomalies

- Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)

- Multiple pregnancy

- Vaginal bleeding at admission

Gender: All

Minimum Age: N/A

Maximum Age: 1 Day

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
sergio M Lerma Narvaez Principal Investigator UTMB, Galveston
Overall Contact

Last Name: SERGIO M LERMA NARVAEZ

Phone: 8326169735

Email: [email protected]

Verification Date

September 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Placental/Umbilical Cord Blood sample

Type: Other

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Masking Description: Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results

Source: ClinicalTrials.gov