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

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ClinicalTrials.gov Identifier: NCT03694613
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Preterm Infant Early-Onset Neonatal Sepsis Umbilical Cord Other: Plancental/Umbilical Cord Blood sample Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
Primary Purpose: Diagnostic
Official 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight Sepsis

Arm Intervention/treatment
Placental/Umbilical Cord Blood sample
Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.
Other: Plancental/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.




Primary Outcome Measures :
  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. I/T ratio (Immature/Total immature neutrophil) [ 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: <0.16

  3. ANC (Absolute Neutrophil Count) (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:500-6000 Cells/mm3

  4. 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: 0.01-0.64mg/dl

  5. 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

  6. Blood culture (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: NEGATIVE

  7. White Blood Cell Count (WBC) (1) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range: 6.000 - 30.000 cell/mm3.

  8. I/T ratio (Immature/Total immature neutrophil) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range: <0.16

  9. ANC (Absolute Neutrophil Count) (2) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range:500-6000 Cells/mm3

  10. CRP (C-Reactive Protein)(2) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range: 0.01-0.64mg/dl

  11. IL-6 (Interleukin-6) (2) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range: 0-10.2 pg/ml

  12. Blood Culture (2) [ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]
    Normal Range: Negative



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694613


Contacts
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Contact: SERGIO M LERMA NARVAEZ 8326169735 senarvae@utmb.edu

Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: sergio M Lerma Narvaez UTMB, Galveston

Publications:

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03694613     History of Changes
Other Study ID Numbers: 18-0165
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Medical Branch, Galveston:
Preterm Infant
Early-Onset Neonatal Sepsis
Umbilical Cord
Complete Cell Count
Placenta
Blood Culture
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Birth Weight
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Body Weight
Signs and Symptoms
Infant, Newborn, Diseases