Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
Primary Purpose
Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placental/Umbilical Cord Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Preterm Infant focused on measuring Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture
Eligibility Criteria
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
Sites / Locations
- Sergio Mauricio Lerma Narvaez
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Placental/Umbilical Cord Blood sample
Arm Description
Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.
Outcomes
Primary Outcome Measures
White Blood Cell Count (WBC) (1)
Normal Range approximately 6,000 - 30,000 cell/mm3.
White Blood Cell Count (WBC) (1) INFANT BLOOD
Normal Range: 6.000 - 30.000 cell/mm3.
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
Normal Range of I/T ratio: <0.2.
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
Normal Range: <0.2
CRP (C-Reactive Protein)(1)
Normal Range: < 10,000 ng/mL
CRP (C-Reactive Protein)(2) INFANT BLOOD
Normal Range: <10.000ng/mL
IL-6 (1)
Normal Range: 0-10.2 pg/ml
IL-6 (Interleukin-6) INFANTS BLOOD
Normal Range: <100 pg/mL
Procalcitonin PUBC
Blood was taken from PUBC after delivery
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Procalcitonin levels
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
Normal Range: Blood Culture Negative
Presepsin- PUBC
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Presepsin-Infant's Blood
Levels of presepsin
Number of Participants With a Negative Blood Culture
Blood is taken from infants after birth
Secondary Outcome Measures
Full Information
NCT ID
NCT03694613
First Posted
September 28, 2018
Last Updated
July 16, 2021
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT03694613
Brief Title
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
Keywords
Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study 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
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placental/Umbilical Cord Blood sample
Arm Type
Other
Arm Description
Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.
Intervention Type
Other
Intervention Name(s)
Placental/Umbilical Cord Blood sample
Intervention 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.
Primary Outcome Measure Information:
Title
White Blood Cell Count (WBC) (1)
Description
Normal Range approximately 6,000 - 30,000 cell/mm3.
Time Frame
Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Title
White Blood Cell Count (WBC) (1) INFANT BLOOD
Description
Normal Range: 6.000 - 30.000 cell/mm3.
Time Frame
Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
Title
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
Description
Normal Range of I/T ratio: <0.2.
Time Frame
Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Title
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
Description
Normal Range: <0.2
Time Frame
Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
Title
CRP (C-Reactive Protein)(1)
Description
Normal Range: < 10,000 ng/mL
Time Frame
Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Title
CRP (C-Reactive Protein)(2) INFANT BLOOD
Description
Normal Range: <10.000ng/mL
Time Frame
Completed during the first 6 hours after birth. This sample was taken directly from the participant.
Title
IL-6 (1)
Description
Normal Range: 0-10.2 pg/ml
Time Frame
Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
Title
IL-6 (Interleukin-6) INFANTS BLOOD
Description
Normal Range: <100 pg/mL
Time Frame
Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
Title
Procalcitonin PUBC
Description
Blood was taken from PUBC after delivery
Time Frame
Within 30 minutes after delivery
Title
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Description
Procalcitonin levels
Time Frame
Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
Title
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
Description
Normal Range: Blood Culture Negative
Time Frame
Blood sample drawn from placenta and from baby within 6 hours after birth.
Title
Presepsin- PUBC
Description
Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth
Time Frame
First 30 min after birth
Title
Presepsin-Infant's Blood
Description
Levels of presepsin
Time Frame
First 30 min after birth
Title
Number of Participants With a Negative Blood Culture
Description
Blood is taken from infants after birth
Time Frame
first 2 hours after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sergio M Lerma Narvaez
Organizational Affiliation
UTMB, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sergio Mauricio Lerma Narvaez
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19106756
Citation
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Citation
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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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