Clinical trial NCT03694613: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Early-Onset Neonatal Sepsis
Umbilical Cord
Keywords: Preterm Infant
Early-Onset Neonatal Sepsis
Umbilical Cord
Complete Cell Count
Placenta
Blood Culture
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 65
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: White Blood Cell Count (WBC) (1)
timeFrame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
measure: White Blood Cell Count (WBC) (1) INFANT BLOOD
timeFrame: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.
measure: I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count
timeFrame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
measure: I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD
timeFrame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.
measure: CRP (C-Reactive Protein)(1)
timeFrame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
measure: CRP (C-Reactive Protein)(2) INFANT BLOOD
timeFrame: Completed during the first 6 hours after birth. This sample was taken directly from the participant.
measure: IL-6 (1)
timeFrame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.
measure: IL-6 (Interleukin-6) INFANTS BLOOD
timeFrame: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.
measure: Procalcitonin PUBC
timeFrame: Within 30 minutes after delivery
measure: Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth
timeFrame: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)
measure: Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth
timeFrame: Blood sample drawn from placenta and from baby within 6 hours after birth.
measure: Presepsin- PUBC
timeFrame: First 30 min after birth
measure: Presepsin-Infant's Blood
timeFrame: First 30 min after birth
measure: Number of Participants With a Negative Blood Culture
timeFrame: first 2 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Sergio Mauricio Lerma Narvaez
state: Texas
Study officials:
affiliation: UTMB, Galveston
name: sergio M Lerma Narvaez
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.