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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placental/Umbilical Cord Blood sample | Other | Placental/Umbilical Cord Blood sample will be collected after delivery from every participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| White Blood Cell Count (WBC) (1) | Normal Range approximately 6,000 - 30,000 cell/mm3. | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
| White Blood Cell Count (WBC) (1) INFANT BLOOD | Normal Range: 6.000 - 30.000 cell/mm3. | Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant. |
| 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. | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
| I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD | Normal Range: <0.2 | Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. |
| CRP (C-Reactive Protein)(1) | Normal Range: < 10,000 ng/mL | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
| CRP (C-Reactive Protein)(2) INFANT BLOOD | Normal Range: <10.000ng/mL | Completed during the first 6 hours after birth. This sample was taken directly from the participant. |
| IL-6 (1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sergio M Lerma Narvaez | UTMB, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sergio Mauricio Lerma Narvaez | Galveston | Texas | 77550 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19106756 | Background | Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available. | |
| 7595778 | Background | Brown DR, Kutler D, Rai B, Chan T, Cohen M. Bacterial concentration and blood volume required for a positive blood culture. J Perinatol. 1995 Mar-Apr;15(2):157-9. |
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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.
Subjects were recruited at the Neonatal Intensive Care of the University of Texas Medical Branch, Galveston, Texas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placental/Umbilical Cord Blood Samples | Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Placental/Umbilical Cord Blood sample: After an 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 a vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2019 |
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Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
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|
Normal Range: 0-10.2 pg/ml |
| Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
| IL-6 (Interleukin-6) INFANTS BLOOD | Normal Range: <100 pg/mL | Completed during the first 6hours after birth. This sample is going to be taken directly from the participant. |
| Procalcitonin PUBC | Blood was taken from PUBC after delivery | Within 30 minutes after delivery |
| Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth | Procalcitonin levels | Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours) |
| 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 | Blood sample drawn from placenta and from baby within 6 hours after birth. |
| Presepsin- PUBC | Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth | First 30 min after birth |
| Presepsin-Infant's Blood | Levels of presepsin | First 30 min after birth |
| Number of Participants With a Negative Blood Culture | Blood is taken from infants after birth | first 2 hours after birth |
| 22531231 | Background | Hornik CP, Benjamin DK, Becker KC, Benjamin DK Jr, Li J, Clark RH, Cohen-Wolkowiez M, Smith PB. Use of the complete blood cell count in early-onset neonatal sepsis. Pediatr Infect Dis J. 2012 Aug;31(8):799-802. doi: 10.1097/INF.0b013e318256905c. |
| 12796229 | Background | Malik A, Hui CP, Pennie RA, Kirpalani H. Beyond the complete blood cell count and C-reactive protein: a systematic review of modern diagnostic tests for neonatal sepsis. Arch Pediatr Adolesc Med. 2003 Jun;157(6):511-6. doi: 10.1001/archpedi.157.6.511. |
| 15102726 | Background | Ng PC. Diagnostic markers of infection in neonates. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F229-35. doi: 10.1136/adc.2002.023838. |
| 14703598 | Background | Laborada G, Rego M, Jain A, Guliano M, Stavola J, Ballabh P, Krauss AN, Auld PA, Nesin M. Diagnostic value of cytokines and C-reactive protein in the first 24 hours of neonatal sepsis. Am J Perinatol. 2003 Nov;20(8):491-501. doi: 10.1055/s-2003-45382. |
| 20723166 | Background | Christensen RD, Lambert DK, Baer VL, Montgomery DP, Barney CK, Coulter DM, Ilstrup S, Bennett ST. Postponing or eliminating red blood cell transfusions of very low birth weight neonates by obtaining all baseline laboratory blood tests from otherwise discarded fetal blood in the placenta. Transfusion. 2011 Feb;51(2):253-8. doi: 10.1111/j.1537-2995.2010.02827.x. Epub 2010 Aug 16. |
| 26392823 | Background | Meena J, Charles MV, Ali A, Ramakrishnan S, Gosh S, Seetha KS. Utility of cord blood culture in early onset neonatal sepsis. Australas Med J. 2015 Aug 31;8(8):263-7. doi: 10.4066/AMJ.2015.2460. eCollection 2015. |
| 22199177 | Background | Beeram MR, Loughran C, Cipriani C, Govande V. Utilization of umbilical cord blood for the evaluation of group B streptococcal sepsis screening. Clin Pediatr (Phila). 2012 May;51(5):447-53. doi: 10.1177/0009922811431882. Epub 2011 Dec 22. |
| 16371391 | Background | Joram N, Boscher C, Denizot S, Loubersac V, Winer N, Roze JC, Gras-Le Guen C. Umbilical cord blood procalcitonin and C reactive protein concentrations as markers for early diagnosis of very early onset neonatal infection. Arch Dis Child Fetal Neonatal Ed. 2006 Jan;91(1):F65-6. doi: 10.1136/adc.2005.074245. |
| 23047426 | Background | Baer VL, Lambert DK, Carroll PD, Gerday E, Christensen RD. Using umbilical cord blood for the initial blood tests of VLBW neonates results in higher hemoglobin and fewer RBC transfusions. J Perinatol. 2013 May;33(5):363-5. doi: 10.1038/jp.2012.127. Epub 2012 Oct 4. |
| COMPLETED |
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| NOT COMPLETED |
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We recruited 65 subjects (41% female) in the study from June 2019 To June 2020. Gestational age was 32.15 + 2.21 weeks and birth weight 1853 + 519 grams.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Birth weight | Mean | Standard Deviation | grams |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | White Blood Cell Count (WBC) (1) | Normal Range approximately 6,000 - 30,000 cell/mm3. | Posted | Mean | Standard Deviation | ratio of cells/mm3 | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
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| Primary | White Blood Cell Count (WBC) (1) INFANT BLOOD | Normal Range: 6.000 - 30.000 cell/mm3. | Infant blood taken from 65 subjects after birth | Posted | Mean | Standard Deviation | ratio of cells/mm3 | Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant. |
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| 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. | Posted | Mean | Standard Deviation | Ratio of Immatures/Total neutrophils | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
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| Primary | I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD | Normal Range: <0.2 | Posted | Mean | Standard Deviation | Immatures/Total neutrophils ratio | Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. |
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| Primary | CRP (C-Reactive Protein)(1) | Normal Range: < 10,000 ng/mL | Posted | Mean | Standard Deviation | ng/mL | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
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| Primary | CRP (C-Reactive Protein)(2) INFANT BLOOD | Normal Range: <10.000ng/mL | Posted | Mean | Standard Deviation | ng/mL | Completed during the first 6 hours after birth. This sample was taken directly from the participant. |
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| Primary | IL-6 (1) | Normal Range: 0-10.2 pg/ml | Posted | Mean | Standard Deviation | ng/mL | Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. |
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| Primary | IL-6 (Interleukin-6) INFANTS BLOOD | Normal Range: <100 pg/mL | Blood was taken from all 65 Infants from placenta and from baby 6 hours after birth | Posted | Mean | Standard Deviation | pg/mL | Completed during the first 6hours after birth. This sample is going to be taken directly from the participant. |
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| Primary | Procalcitonin PUBC | Blood was taken from PUBC after delivery | PUBC from all 65 subjects recruited | Posted | Mean | Standard Deviation | pg/mL | Within 30 minutes after delivery |
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| Primary | Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth | Procalcitonin levels | Posted | Mean | Standard Deviation | pg/mL | Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours) |
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| 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 | 65 out of 65 subjects were reported to have NEGATIVE blood cultures | Posted | Count of Participants | Participants | Blood sample drawn from placenta and from baby within 6 hours after birth. |
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| Primary | Presepsin- PUBC | Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth | Posted | Mean | Standard Deviation | ng/mL | First 30 min after birth |
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| Primary | Presepsin-Infant's Blood | Levels of presepsin | Posted | Mean | Standard Deviation | ng/mL | First 30 min after birth |
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| Primary | Number of Participants With a Negative Blood Culture | Blood is taken from infants after birth | A negative blood culture indicates no infection | Posted | Count of Participants | Participants | first 2 hours after birth |
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12 months
No reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placental/Umbilical Cord Blood Sample | Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. 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. | 0 | 65 | 0 | 65 | 0 | 65 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sergio Lerma | Fundacion Santa Fe, Bogotá, Colombia | +57 3017752726 | serlerma@gmail.com |
| May 14, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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