N/A
N=65
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
Preterm Infant · Early-Onset Neonatal Sepsis · Umbilical Cord
Bottom Line
View on ClinicalTrials.gov: NCT03694613 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: White Blood Cell Count (WBC) (1) — 8257 ratio of cells/mm3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placental/Umbilical Cord Blood sample (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY White Blood Cell Count (WBC) (1) |
8257 | — |
| PRIMARY White Blood Cell Count (WBC) (1) INFANT BLOOD |
7055 | — |
| PRIMARY I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count |
0.09 | — |
| PRIMARY I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD |
0.12 | — |
| PRIMARY CRP (C-Reactive Protein)(1) |
413 | — |
| PRIMARY CRP (C-Reactive Protein)(2) INFANT BLOOD |
785 | — |
| PRIMARY IL-6 (1) |
61.45; 45.36 | — |
| PRIMARY IL-6 (Interleukin-6) INFANTS BLOOD |
45.36 | — |
| PRIMARY Procalcitonin PUBC |
185.9 | — |
| PRIMARY Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth |
131.4 | — |
| PRIMARY Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth |
65 | — |
| PRIMARY Presepsin- PUBC |
4.6 | — |
| PRIMARY Presepsin-Infant's Blood |
5.3 | — |
| PRIMARY Number of Participants With a Negative Blood Culture |
65 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03694613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.