NEONATAL SEPSISNCT05585957
THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
A study testing INTERLEUKIN 6 in people with NEONATAL SEPSIS, run by Sohag University at 1 site in Egypt.
Trial summary
Neonatal sepsis is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence… Read more about this study
- Who is it for?
- Ages 1 hour to 3 months
- Conditions the study is for
- NEONATAL SEPSIS
- What is being tested?
- INTERLEUKIN 6
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 May 2023
- Phase
- Interventional
- 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 1 hour to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.
Who cannot join
- Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture
Trial locations and contacts
1 site in 1 country.
Ashraf K Mohammad, Assistant professor contact
About this study
Neonatal sepsis is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence of neonatal septicemia increases to 49 to 170 cases per 1000 live births. The normal fetus is sterile until shortly before birth as the placenta and amniotic sac are highly effective barriers to infections. At birth, the newborn loses the protection afforded to it in the uterus and gets exposed to the microbial world.Neonatal sepsis is broadly divided into two types according to age of onset: Early-onset sepsis (<72 Hrs) and late-onset sepsis (≥72 hrs-28 days). Early-onset sepsis is acquired during fetal life, delivery, or at the nursery.Bacterial organisms causing NS may differ among countries, however, in most developing countries, gram-negative bacteria remain the major source of infection.To date, blood culture is the gold standard test for diagnosing sepsis, but it has some inherent limitations. It takes at least three or five days to be decisive and can be mistakenly negative because antibiotics are initiated empirically before collection and a well-developed microbiology laboratory is required.CRP is one of the most widely studied and applied acute phase proteins clinically, which can be induced by pre-inflammatory factor interleukin-6 (IL-6) to synthesize by liver cells, and it starts to rise in 12-24 hours of inflammatory response and reaches its peak at 48 hours.Interleukin-6 (IL-6) is a pleiotropic cytokine expressed by different cells in response to infections.
- Conditions
- NEONATAL SEPSIS
- Being tested
- INTERLEUKIN 6
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERLEUKIN 6Diagnostic test
role of interleukin 6 in the diagnosis of neonatal sepsis in comparison with the routine diagnostic markers of neonatal sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
level of interleukin 6
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 posted19 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NEONATAL SEPSISStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Faisal Hamdallah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585957
- Sponsor's protocol ID
- Soh-Med-22-10-08
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guo J, Luo Y, Wu Y, Lai W, Mu X. Clinical Characteristic and Pathogen Spectrum of Neonatal Sepsis in Guangzhou City from June 2011 to June 2017. Med Sci Monit. 2019 Mar 29;25:2296-2304. doi: 10.12659/MSM.912375.
PubMed 30924465Habib A, Raza S, Ali U, Zubairi AM, Salim E. Diagnostic Accuracy of Serum Procalcitonin (PCT) as an Early Biomarker of Neonatal Sepsis using Blood Culture as Gold Standard. J Coll Physicians Surg Pak. 2021 Apr;31(4):383-387. doi: 10.29271/jcpsp.2021.04.383.
PubMed 33866721Kan B, Razzaghian HR, Lavoie PM. An Immunological Perspective on Neonatal Sepsis. Trends Mol Med. 2016 Apr;22(4):290-302. doi: 10.1016/j.molmed.2016.02.001. Epub 2016 Mar 15.
PubMed 26993220Liu C, Fang C, He Q, Xie L. The value of interleukin-6 (IL-6) within 6 hours after birth in the prompt diagnosis of early-onset neonatal sepsis. Transl Pediatr. 2020 Oct;9(5):629-635. doi: 10.21037/tp-20-239.
PubMed 33209725
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
- ClinicalTrials.gov ID
- NCT05585957
- Acronym / sponsor ID
- Soh-Med-22-10-08
- Conditions
- NEONATAL SEPSIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 19 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 is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence of neonatal septicemia increases to 49 to 170 cases per 1000 live births. The normal fetus is sterile until shortly before birth as the placenta and amniotic sac are highly effective barriers to infections. At birth, the newborn loses the protection afforded to it in the uterus and gets exposed to the microbial world.Neonatal sepsis is broadly divided into two types according to age of onset: Early-onset sepsis (<72 Hrs) and late-onset sepsis (≥72 hrs-28 days). Early-onset sepsis is acquired during fetal life, delivery, or at the nursery.Bacterial organisms causing NS may differ among countries, however, in most developing countries, gram-negative bacteria remain the major source of infection.To date, blood culture is the gold standard test for diagnosing sepsis, but it has some inherent limitations. It takes at least three or five days to be decisive and can be mistakenly negative because antibiotics are initiated empirically before collection and a well-developed microbiology laboratory is required.CRP is one of the most widely studied and applied acute phase proteins clinically, which can be induced by pre-inflammatory factor interleukin-6 (IL-6) to synthesize by liver cells, and it starts to rise in 12-24 hours of inflammatory response and reaches its peak at 48 hours.Interleukin-6 (IL-6) is a pleiotropic cytokine expressed by different cells in response to infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 hour to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.
Key exclusion criteria (1 listed)
- Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture
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 |
|---|---|---|
| INTERLEUKIN 6role of interleukin 6 in the diagnosis of neonatal sepsis in comparison with the routine diagnostic markers of neonatal sepsis | Diagnostic test | – |
Primary outcome
level of interleukin 6
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 19 Oct 2022.
- Background: PubMed 30924465Guo J, Luo Y, Wu Y, Lai W, Mu X. Clinical Characteristic and Pathogen Spectrum of Neonatal Sepsis in Guangzhou City from June 2011 to June 2017. Med Sci Monit. 2019 Mar 29;25:2296-2304. doi: 10.12659/MSM.912375.
- Background: PubMed 33866721Habib A, Raza S, Ali U, Zubairi AM, Salim E. Diagnostic Accuracy of Serum Procalcitonin (PCT) as an Early Biomarker of Neonatal Sepsis using Blood Culture as Gold Standard. J Coll Physicians Surg Pak. 2021 Apr;31(4):383-387. doi: 10.29271/jcpsp.2021.04.383.
- Background: PubMed 26993220Kan B, Razzaghian HR, Lavoie PM. An Immunological Perspective on Neonatal Sepsis. Trends Mol Med. 2016 Apr;22(4):290-302. doi: 10.1016/j.molmed.2016.02.001. Epub 2016 Mar 15.
- Background: PubMed 33209725Liu C, Fang C, He Q, Xie L. The value of interleukin-6 (IL-6) within 6 hours after birth in the prompt diagnosis of early-onset neonatal sepsis. Transl Pediatr. 2020 Oct;9(5):629-635. doi: 10.21037/tp-20-239.
- Individual participant dataSharing planned: Undecided
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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.
Ashraf K Mohammad, Assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERLEUKIN 6 in people with NEONATAL SEPSIS, run by Sohag University at 1 site in Egypt.
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 19 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 Egypt. 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 Doha F Hamd-Allah, Resident (01067567337, dohafaisel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of interleukin 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585957, which also lists 4 linked publications.
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 19 Oct 2022.