NCT03694613

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

Completed NA Results posted Last updated 10 August 2021

What this trial tests

NA trial testing Placental/Umbilical Cord Blood sample in Preterm Infant in 65 participants. Completed in 20 August 2020.

Timeline

1 June 2019

Primary endpoint
1 June 2020

20 August 2020

Quick facts

Lead sponsor	The University of Texas Medical Branch, Galveston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	65
Start date	1 June 2019
Primary completion	1 June 2020
Estimated completion	20 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Placental/Umbilical Cord Blood sample

Conditions studied

• Preterm Infant — all drugs for Preterm Infant →
• Early-Onset Neonatal Sepsis — all drugs for Early-Onset Neonatal Sepsis →
• Umbilical Cord — all drugs for Umbilical Cord →

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Under 1 Day, any sex, with Preterm Infant or Early-Onset Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

White Blood Cell Count (WBC) (1) Primary · 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.

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	8257	± 2966

White Blood Cell Count (WBC) (1) INFANT BLOOD Primary · 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.

Group	Value	95% CI
WBC- INFANT BLOOD	7055	± 12400

I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count Primary · 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.

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	0.09	± 0.13

I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD Primary · Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

Normal Range: \<0.2

Group	Value	95% CI
I/T Ratio. INFANT BLOOD	0.12	± 0.13

CRP (C-Reactive Protein)(1) Primary · 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

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	413	± 1229

CRP (C-Reactive Protein)(2) INFANT BLOOD Primary · Completed during the first 6 hours after birth. This sample was taken directly from the participant.

Normal Range: \<10.000ng/mL

Group	Value	95% CI
CRP- INFANT BLOOD	785	± 1846

IL-6 (1) Primary · 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

PUCB

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	61.45	± 392.7

INFANT BLOOD

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	45.36	± 182.3

IL-6 (Interleukin-6) INFANTS BLOOD Primary · Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.

Normal Range: \<100 pg/mL

Group	Value	95% CI
IL-6 - INFANT BLOOD	45.36	± 182.3

Procalcitonin PUBC Primary · Within 30 minutes after delivery

Blood was taken from PUBC after delivery

Group	Value	95% CI
Procalcitonin - PUBC	185.9	± 374

Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth Primary · Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)

Procalcitonin levels

Group	Value	95% CI
Procalcitonin - Infant's Blood	131.4	± 411.7

Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth Primary · Blood sample drawn from placenta and from baby within 6 hours after birth.

Normal Range: Blood Culture Negative

Group	Value	95% CI
Placental/Umbilical Cord Blood Sample	65

Presepsin- PUBC Primary · First 30 min after birth

Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth

Group	Value	95% CI
PRESEPSIN- PUCB	4.6	± 1.6

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Application of Umbilical Cord Blood for the Clinical Prevention and Treatment of Complications in Preterm Infants(Review).
   Xu L, Shuzhe X, Jie Y. · · 2026 · PMID 41021185 · DOI 10.1007/s12015-025-10988-4