Neonatal SepsisNCT06633770
Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
An observational study of Neonatal Sepsis, run by Sohag University at 1 site in Egypt.
Trial summary
-Introduction: Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- proclcitonin and presepsin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis
Who may be able to join
- Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (PROM), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension).
Who cannot join
- Administration of antibiotic therapy prior to admission, Birth asphyxia Laboratory finding suggestive of inborn error of metabolism Congenital anomalies including congenital heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed s sedky, assistant professor contact
About this study
-Introduction: Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. Early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome.
Neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria , viruses, fungi ,or parasites or the toxic products of these., It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges .The proof of infection is seldom encountered in practice, as the confirmatory microbial culture yield can be as low as 25-30%. Hence, clinicians often depend on commonly available biomarkers such as C-reactive Protein (CRP) and procalcitonin (PCT) for diagnosing infection. Even though helpful, these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry.
CD14 is a co-receptor present on the surface of the monocyte/macrophage. It is a member of the Toll-like receptors (TLRs),with an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound (mCD14) and a soluble form (sCD14). The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D . The N terminal fragment of the sCD14-ST subtype is called presepsin.
- Conditions
- Neonatal Sepsis
- Being tested
- proclcitonin and presepsin
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proclcitonin and presepsinDiagnostic test
All included patients will be subjected to:
- laboratory investigations
- Complete Blood Count (CBC),
- Liver Function Test(LFT) ( ALT,AST, Billirubin, total protein and albumin)
- Kidney function test (KFT) ( Urea and creatinine)
- Random Blood Glucose (RBG).
- Erythrocyte Sedimentation Rate(ESR )
- Urine analysis -A special investigations include (blood culture, C Reactive protein (CRP), proclcitonin and presepsin).
| Study group | Role | What they receive |
|---|---|---|
| (case group): | Consists of 70 neonates, whose blood culture results were positive and indicative of known sepsis-causing pathogens and neonates whose clinical and laboratory findings were indicative of probable sepsis despite negative blood culture results.
Clinical and laboratory findings were indicative of probable sepsis :
* Fever or low temperature.
* Fast or slow heart rate.
* Fast breathing or shortness of breath.
* Vomiting.
* Diarrhea.
* Reduced sucking/difficulty feeding.
* Swollen belly (abdomen).
* Cold hands and feet.
* Leukocyte (<5000 or ≥20000 wbcs/ µL), absolute neutrophil (>60%) a
* Thrombocytopenia: Receives: Diagnostic Test: proclcitonin and presepsin | |
| control group | 30 healthy neonates who had no signs of sepsis in clinical, radiographic, or laboratory findings or whose symptoms could be characteristic of another disease. Receives: Diagnostic Test: proclcitonin and presepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Saleh Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633770
- Sponsor's protocol ID
- soh-Med-24-09-11MS
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Strunk T, Molloy EJ, Mishra A, Bhutta ZA. Neonatal bacterial sepsis. Lancet. 2024 Jul 20;404(10449):277-293. doi: 10.1016/S0140-6736(24)00495-1. Epub 2024 Jun 26.
PubMed 38944044Pospisilova I, Brodska HL, Bloomfield M, Borecka K, Janota J. Evaluation of presepsin as a diagnostic tool in newborns with risk of early-onset neonatal sepsis. Front Pediatr. 2023 Jan 9;10:1019825. doi: 10.3389/fped.2022.1019825. eCollection 2022.
PubMed 36699313Wei S, Shen Z, Yin Y, Cong Z, Zeng Z, Zhu X. Advances of presepsin in sepsis-associated ARDS. Postgrad Med J. 2024 Mar 18;100(1182):209-218. doi: 10.1093/postmj/qgad132.
PubMed 38147883Krack AT, Eckerle M, Mahajan P, Ramilo O, VanBuren JM, Banks RK, Casper TC, Schnadower D, Kuppermann N; Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN). Leukopenia, neutropenia, and procalcitonin levels in young febrile infants with invasive bacterial infections. Acad Emerg Med. 2024 Sep;31(9):903-914. doi: 10.1111/acem.14921. Epub 2024 Apr 25.
PubMed 38661246Poggi C, Lucenteforte E, Petri D, De Masi S, Dani C. Presepsin for the Diagnosis of Neonatal Early-Onset Sepsis: A Systematic Review and Meta-analysis. JAMA Pediatr. 2022 Aug 1;176(8):750-758. doi: 10.1001/jamapediatrics.2022.1647.
PubMed 35639395
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT06633770
- Acronym / sponsor ID
- soh-Med-24-09-11MS
- Conditions
- Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 9 Oct 2024 (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.
-Introduction: Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. Early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome.
Neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria , viruses, fungi ,or parasites or the toxic products of these., It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges .The proof of infection is seldom encountered in practice, as the confirmatory microbial culture yield can be as low as 25-30%. Hence, clinicians often depend on commonly available biomarkers such as C-reactive Protein (CRP) and procalcitonin (PCT) for diagnosing infection. Even though helpful, these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry.
CD14 is a co-receptor present on the surface of the monocyte/macrophage. It is a member of the Toll-like receptors (TLRs),with an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound (mCD14) and a soluble form (sCD14). The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D . The N terminal fragment of the sCD14-ST subtype is called presepsin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (case group): | – | Diagnostic Test: proclcitonin and presepsinConsists of 70 neonates, whose blood culture results were positive and indicative of known sepsis-causing pathogens and neonates whose clinical and laboratory findings were indicative of probable sepsis despite negative blood culture results. Clinical and laboratory findings were indicative of probable sepsis : * Fever or low temperature. * Fast or slow heart rate. * Fast breathing or shortness of breath. * Vomiting. * Diarrhea. * Reduced sucking/difficulty feeding. * Swollen belly (abdomen). * Cold hands and feet. * Leukocyte (<5000 or ≥20000 wbcs/ µL), absolute neutrophil (>60%) a * Thrombocytopenia: |
| control group | – | Diagnostic Test: proclcitonin and presepsin30 healthy neonates who had no signs of sepsis in clinical, radiographic, or laboratory findings or whose symptoms could be characteristic of another disease. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis
Key inclusion criteria (1 listed)
- Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (PROM), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension).
Key exclusion criteria (1 listed)
- Administration of antibiotic therapy prior to admission, Birth asphyxia Laboratory finding suggestive of inborn error of metabolism Congenital anomalies including congenital heart disease
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 |
|---|---|---|
| proclcitonin and presepsinAll included patients will be subjected to: * laboratory investigations * Complete Blood Count (CBC), * Liver Function Test(LFT) ( ALT,AST, Billirubin, total protein and albumin) * Kidney function test (KFT) ( Urea and creatinine) * Random Blood Glucose (RBG). * Erythrocyte Sedimentation Rate(ESR ) * Urine analysis -A special investigations include (blood culture, C Reactive protein (CRP), proclcitonin and presepsin). | Diagnostic test | (case group):, control group |
Primary outcome
• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 38944044Strunk T, Molloy EJ, Mishra A, Bhutta ZA. Neonatal bacterial sepsis. Lancet. 2024 Jul 20;404(10449):277-293. doi: 10.1016/S0140-6736(24)00495-1. Epub 2024 Jun 26.
- Background: PubMed 36699313Pospisilova I, Brodska HL, Bloomfield M, Borecka K, Janota J. Evaluation of presepsin as a diagnostic tool in newborns with risk of early-onset neonatal sepsis. Front Pediatr. 2023 Jan 9;10:1019825. doi: 10.3389/fped.2022.1019825. eCollection 2022.
- Background: PubMed 38147883Wei S, Shen Z, Yin Y, Cong Z, Zeng Z, Zhu X. Advances of presepsin in sepsis-associated ARDS. Postgrad Med J. 2024 Mar 18;100(1182):209-218. doi: 10.1093/postmj/qgad132.
- Background: PubMed 38661246Krack AT, Eckerle M, Mahajan P, Ramilo O, VanBuren JM, Banks RK, Casper TC, Schnadower D, Kuppermann N; Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN). Leukopenia, neutropenia, and procalcitonin levels in young febrile infants with invasive bacterial infections. Acad Emerg Med. 2024 Sep;31(9):903-914. doi: 10.1111/acem.14921. Epub 2024 Apr 25.
- Background: PubMed 35639395Poggi C, Lucenteforte E, Petri D, De Masi S, Dani C. Presepsin for the Diagnosis of Neonatal Early-Onset Sepsis: A Systematic Review and Meta-analysis. JAMA Pediatr. 2022 Aug 1;176(8):750-758. doi: 10.1001/jamapediatrics.2022.1647.
- 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.
ahmed s sedky, assistant professor contact
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, 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: opening soon, as of the sponsor's last update on 9 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara s saleh, resident (01112164307, sara_saleh_post@med.sohag0edu0eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis (time frame: 4 years). 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 NCT06633770, which also lists 5 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 9 Oct 2024.