Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
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
Lead Sponsor: The University of Texas Medical Branch, Galveston
|Source||The University of Texas Medical Branch, Galveston|
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.
|Overall Status||Unknown status|
|Start Date||April 1, 2019|
|Completion Date||June 2020|
|Primary Completion Date||April 2020|
Intervention Type: Other
Intervention Name: Plancental/Umbilical Cord Blood sample
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.
Arm Group Label: Placental/Umbilical Cord Blood sample
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
- Infants <30 weeks' gestational and <1250 grams birth weight
- 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
Minimum Age: N/A
Maximum Age: 1 Day
Healthy Volunteers: No
Last Name: SERGIO M LERMA NARVAEZ
Email: [email protected]
|Has Expanded Access||No|
|Number Of Arms||1|
Label: Placental/Umbilical Cord Blood sample
Description: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.
|Study Design Info||
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)
Masking Description: Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results