Neonatal Sepsis, Early-OnsetNCT05589909
Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis
An observational study of Neonatal Sepsis, Early-Onset, run by Mansoura University Children Hospital at 1 site in United Arab Emirates.
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… Read more about this study
- Who is it for?
- Ages 0 minutes to 24 hours
- Conditions the study is for
- Neonatal Sepsis, Early-Onset
- What is being tested?
- IL27, PCT, CRP, Blood culture
- How many people
- 548 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 20 Jun 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: These risk factors included maternal fever, prolonged rupture of membranes with leaking amniotic fluid 18 hours or more before delivery, maternal bacterial infection including urinary tract infection or evidence of maternal colonization with group B streptococcus (GBS).
Who may be able to join
- All newborn infants born to pregnant women who had one or more of antenatal risk factors for sepsis. on or evidence of maternal colonization with group B streptococcus (GBS).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Mansoura University Children Hospital
Abu Dhabi
wael seliem, MD, 0545873838, wseliem@hotmail.com
About this study
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.
Read more
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.
Read the detailed 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
- Conditions
- Neonatal Sepsis, Early-Onset
- Being tested
- IL27, PCT, CRP, Blood culture
- Keywords
- Early onset neonatal sepsis, Procalcitonin, Interleukin-27.
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL27, PCT, CRP, Blood cultureDiagnostic test
magnetic bead multiplex platform
| Study group | Role | What they receive |
|---|---|---|
| Infection Group | Both suspected and confirmed sepsis occurred ≤72 hours after delivery were counted as cases of EONS. Receives: Diagnostic Test: IL27, PCT, CRP, Blood culture | |
| None Infection Group | No evidence clinical or laboratory of infection Receives: Diagnostic Test: IL27, PCT, CRP, Blood culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of IL27, PCT and CRP levels in umbilical cord blood
comparison between 2 groups
Measured: 6 months
Secondary outcomes (1)
Measurement of IL27, PCT and CRP levels in blood after 24 hours
comparison between 2 groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start20 Jun 2022
- Primary completion22 Oct 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Sepsis, Early-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Seliem, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589909
- Sponsor's protocol ID
- R.22.03.1667
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If not used in extended research work
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT05589909
- Acronym / sponsor ID
- R.22.03.1667
- Conditions
- Neonatal Sepsis, Early-Onset
- Keywords
- Early onset neonatal sepsis, Procalcitonin, Interleukin-27.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 22 Oct 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection Group | – | Diagnostic Test: IL27, PCT, CRP, Blood cultureBoth suspected and confirmed sepsis occurred ≤72 hours after delivery were counted as cases of EONS. |
| None Infection Group | – | Diagnostic Test: IL27, PCT, CRP, Blood cultureNo evidence clinical or laboratory of infection |
Who may qualify
- Ages
- 0 minutes to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- These risk factors included maternal fever, prolonged rupture of membranes with leaking amniotic fluid 18 hours or more before delivery, maternal bacterial infection including urinary tract infection or evidence of maternal colonization with group B streptococcus (GBS).
Key inclusion criteria (1 listed)
- All newborn infants born to pregnant women who had one or more of antenatal risk factors for sepsis. on or evidence of maternal colonization with group B streptococcus (GBS).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL27, PCT, CRP, Blood culturemagnetic bead multiplex platform | Diagnostic test | Infection Group, None Infection Group |
Primary outcome
Measurement of IL27, PCT and CRP levels in umbilical cord blood
Time frame: 6 months
comparison between 2 groups
1 secondary outcome
Measurement of IL27, PCT and CRP levels in blood after 24 hours
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: Undecided. If not used in extended research work
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis, Early-Onset, run by Mansoura University Children Hospital at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wael seliem, MD (00971545873838, wseliem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of IL27, PCT and CRP levels in umbilical cord blood (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.