Skip to main content
OpenTrials
Completed

NCT Number: NCT03694613

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infant Congenital, Hereditary, and Neonatal Diseases and Abnormalities Early-Onset Neonatal Sepsis Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Umbilical Cord Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sergio Mauricio Lerma Narvaez

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placental/Umbilical Cord Blood sample

Other

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.

Primary outcomes

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

    Time frame: 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.

  2. White Blood Cell Count (WBC) (1) INFANT BLOOD

    Time frame: 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.

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

    Time frame: 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.

  4. I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD

    Time frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

    Normal Range: <0.2

  5. CRP (C-Reactive Protein)(1)

    Time frame: 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

  6. CRP (C-Reactive Protein)(2) INFANT BLOOD

    Time frame: Completed during the first 6 hours after birth. This sample was taken directly from the participant.

    Normal Range: <10.000ng/mL

  7. IL-6 (1)

    Time frame: 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

  8. IL-6 (Interleukin-6) INFANTS BLOOD

    Time frame: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.

    Normal Range: <100 pg/mL

  9. Procalcitonin PUBC

    Time frame: Within 30 minutes after delivery

    Blood was taken from PUBC after delivery

  10. Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth

    Time frame: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)

    Procalcitonin levels

  11. Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth

    Time frame: Blood sample drawn from placenta and from baby within 6 hours after birth.

    Normal Range: Blood Culture Negative

  12. Presepsin- PUBC

    Time frame: First 30 min after birth

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

  13. Presepsin-Infant's Blood

    Time frame: First 30 min after birth

    Levels of presepsin

  14. Number of Participants With a Negative Blood Culture

    Time frame: first 2 hours after birth

    Blood is taken from infants after birth

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2018
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.