Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05589909 |
| Other study ID # |
R.22.03.1667 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Mansoura University Children Hospital |
| Contact |
wael seliem, MD |
| Phone |
00971545873838 |
| Email |
wseliem[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Neonatal sepsis still considered as one of the major causes of mortality and morbidity during
the neonatal period due to high vulnerability of that age group. The blood culture is
considered as the gold standard for diagnosis of bacterial sepsis, however in early onset
neonatal sepsis (EONS) the inability to isolate a microbial pathogen does not exclude sepsis.
The reason behind the high number of culture-negative cases is not clear and might be
attributed to low levels of bacteremia or small volumes of blood obtained from sick infants.
Also maternal antibiotic treatment before or during delivery may theoretically mask detection
of bacteremia in the newborn. In addition these cultures have a 48-72 hours delay to obtain
results. Therefore, the combination of clinical assessment and laboratory biomarkers
currently are the bases for diagnosis of neonatal sepsis.
Recently interleukin-27 (IL-27) has been looked at as another candidate biomarker in the
serum for diagnosis of sepsis in both adult and children. Interleukin-27 (IL-27), a novel
member of the IL-12 family, was first discovered in 2002. IL- 27 is primarily synthesized by
antigen-presenting cells, and it is widely expressed in a myriad of cells, including
placental trophoblast cells. Although multiple studies have reported IL-27 as an essential
regulator of immune response and inflammation, its precise role in the immune response is
still disputable.
Conventionally, IL-27 has been envisaged as a potent promoter of inflammation. When first
discovered, it was characterized as a promoting factor in the rapid initiation of
inflammatory responses, processing the ability to stimulate the rapid expansion of naïve
CD4+T and then the production of IFN-?, which has been demonstrated by various subsequent
studies.
The aim of this study was to evaluate the usage of elevated IL-27 in cord blood as an early
predictor biomarker for EONS.
Description:
A prospective study will be conducted in the neonatal intensive care unit (NICU), Mansoura
University Children Hospital -over a period of one year. The study subjects will include all
newborn infants born to pregnant women with one or more of antenatal risk factors for sepsis
including maternal fever, prolonged rupture of membranes with leakage of amniotic fluid
preceding the onset of labor for 18 hours or more, presence of chorioamnionitis or evidence
of maternal colonization with group B streptococcus (GBS). Prematurity was defined as
gestational age of 36+6 weeks and less.
Blood samples for biomarkers detection will be collected from the umbilical artery after
clamping the umbilical cords before delivery of the placenta. The blood will be collected in
ethylene diamine tetra-acetic acid-containing tubes from each infant for immunological
detection of IL-27, procalcitonin and C-reactive protein.
For neonatal blood culture, blood samples will be collected from each neonate, before
starting any antimicrobial treatment, by venous puncture from a peripheral vein for blood
culture. About 1 mL of blood will be directly inoculated into a pediatric blood culture
bottle and sent to the Medical Microbiology and Immunology Department, Mansoura University,
Egypt for subsequent microbiological processing. Obtained bacterial isolates will be
identified by standard microbiological techniques
