Early-Onset Neonatal Sepsis, Preterm Infant, Umbilical Cord
Conditions
Keywords
Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord, Complete Cell Count, Placenta, Blood Culture
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.
Interventions
OTHERPlacental/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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Normal Range approximately 6,000 - 30,000 cell/mm3. |
| White Blood Cell Count (WBC) (1) INFANT BLOOD | 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. |
| I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count | 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. |
| I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD | Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. | Normal Range: \<0.2 |
| 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. | Normal Range: \< 10,000 ng/mL |
| CRP (C-Reactive Protein)(2) INFANT BLOOD | Completed during the first 6 hours after birth. This sample was taken directly from the participant. | Normal Range: \<10.000ng/mL |
| 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. | Normal Range: 0-10.2 pg/ml |
| IL-6 (Interleukin-6) INFANTS BLOOD | Completed during the first 6hours after birth. This sample is going to be taken directly from the participant. | Normal Range: \<100 pg/mL |
| Procalcitonin PUBC | Within 30 minutes after delivery | 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 Level was measured in the blood from placenta and in Infant's Blood (within 6 hours) | Procalcitonin levels |
| Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth | Blood sample drawn from placenta and from baby within 6 hours after birth. | Normal Range: Blood Culture Negative |
| Presepsin- PUBC | First 30 min after birth | Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth |
| Presepsin-Infant's Blood | First 30 min after birth | Levels of presepsin |
| Number of Participants With a Negative Blood Culture | first 2 hours after birth | Blood is taken from infants after birth |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at the Neonatal Intensive Care of the University of Texas Medical Branch, Galveston, Texas.
Pre-assignment details
We included 65 PI \<34 weeks, who were screened for EOS and admitted to the NICU (June 2019 to June 2020). Infants with known lethal chromosomal or congenital anomalies were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Placental/Umbilical Cord Blood Sample Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.
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. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Placental/Umbilical Cord Blood Sample |
|---|---|
| Age, Continuous | 32.15 Weeks STANDARD_DEVIATION 2.21 |
| Birth weight | 1853 grams STANDARD_DEVIATION 519 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
CRP (C-Reactive Protein)(1)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | CRP (C-Reactive Protein)(1) | 413 ng/mL | Standard Deviation 1229 |
Primary
CRP (C-Reactive Protein)(2) INFANT BLOOD
Normal Range: \<10.000ng/mL
Time frame: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | CRP (C-Reactive Protein)(2) INFANT BLOOD | 785 ng/mL | Standard Deviation 1846 |
Primary
IL-6 (1)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | IL-6 (1) | PUCB | 61.45 ng/mL | Standard Deviation 392.7 |
| Placental/Umbilical Cord Blood Sample | IL-6 (1) | INFANT BLOOD | 45.36 ng/mL | Standard Deviation 182.3 |
Primary
IL-6 (Interleukin-6) INFANTS BLOOD
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.
Population: Blood was taken from all 65 Infants from placenta and from baby 6 hours after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | IL-6 (Interleukin-6) INFANTS BLOOD | 45.36 pg/mL | Standard Deviation 182.3 |
Primary
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.
Time frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count | 0.09 Ratio of Immatures/Total neutrophils | Standard Deviation 0.13 |
Primary
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD | 0.12 Immatures/Total neutrophils ratio | Standard Deviation 0.13 |
Primary
Number of Participants With a Negative Blood Culture
Blood is taken from infants after birth
Time frame: first 2 hours after birth
Population: A negative blood culture indicates no infection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placental/Umbilical Cord Blood Sample | Number of Participants With a Negative Blood Culture | 65 Participants |
Primary
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
Time frame: Blood sample drawn from placenta and from baby within 6 hours after birth.
Population: 65 out of 65 subjects were reported to have NEGATIVE blood cultures
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placental/Umbilical Cord Blood Sample | Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth | 65 Participants |
Primary
Presepsin-Infant's Blood
Levels of presepsin
Time frame: First 30 min after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | Presepsin-Infant's Blood | 5.3 ng/mL | Standard Deviation 2 |
Primary
Presepsin- PUBC
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | Presepsin- PUBC | 4.6 ng/mL | Standard Deviation 1.6 |
Primary
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
Procalcitonin levels
Time frame: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth | 131.4 pg/mL | Standard Deviation 411.7 |
Primary
Procalcitonin PUBC
Blood was taken from PUBC after delivery
Time frame: Within 30 minutes after delivery
Population: PUBC from all 65 subjects recruited
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | Procalcitonin PUBC | 185.9 pg/mL | Standard Deviation 374 |
Primary
White Blood Cell Count (WBC) (1)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | White Blood Cell Count (WBC) (1) | 8257 ratio of cells/mm3 | Standard Deviation 2966 |
Primary
White Blood Cell Count (WBC) (1) INFANT BLOOD
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.
Population: Infant blood taken from 65 subjects after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placental/Umbilical Cord Blood Sample | White Blood Cell Count (WBC) (1) INFANT BLOOD | 7055 ratio of cells/mm3 | Standard Deviation 12400 |