Late Onset Neonatal SepsisNCT07821190
MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates
An observational study of Late Onset Neonatal Sepsis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term clinical outcomes Read more about this study
- Who is it for?
- Ages 73 hours to 28 days
- Conditions the study is for
- Late Onset Neonatal Sepsis
- What is being tested?
- MDW measurement
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Jul 2027
- 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 73 hours to 28 days
- All sexes
- Child
Study population: A total of 60 preterm neonates with clinical suspicion of late-onset neonatal sepsis (LONS) will be included. All eligible neonates admitted to the Neonatal Intensive Care Unit (NICU) of the Pediatrics Department, Tanta University Hospitals, will be screened, and those meeting the inclusion criteria will be enrolled consecutively at the time of first clinical suspicion of sepsis
Who may be able to join
- Preterm neonates with gestational age <37 weeks.
- Neonates aged >72 hours of life at the time of enrollment.
- Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following:
- Temperature instability (core temperature >38°C or <36°C)
- Respiratory distress or new-onset apnea
- Feeding intolerance or poor feeding
Show all 10Show fewer
- Lethargy or irritability
- Bradycardia or tachycardia
- Hypotension
- Unexplained clinical deterioration
Who cannot join
- Neonates with any of the following will be excluded from the study:
- Early onset neonatal sepsis.
- Major congenital anomalies
- Chromosomal abnormalities
- Metabolic disorders
- Severe perinatal asphyxia
- Neonates with surgical conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Tanta University
Tanta
Faculty of Medicine, Tanta University, 2+ 040 3337544, dean@med.tanta.edu.eg
About this study
Official title: Monocyte Distribution Width as a Novel Diagnostic Biomarker in Late-Onset Sepsis Among Preterm Neonates
This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term clinical outcomes
Read the detailed description
Neonatal sepsis is a major cause of morbidity and mortality among newborns worldwide. It represents a systemic inflammatory response to infection that can rapidly progress to severe complications, including multi-organ dysfunction and death. The clinical presentation is often nonspecific, making early diagnosis challenging and frequently delayed. The diagnosis of LOS relies on a combination of clinical suspicion, microbiological confirmation, and supportive laboratory findings. Blood culture remains the gold standard for diagnosis, as it confirms the infection and identifies the causative organism, allowing for targeted antibiotic therapy. Biomarkers play an essential role in the early detection and management of sepsis. Commonly used biomarkers include C-reactive protein (CRP), an indicator of systemic inflammation and infection. However, these markers have limitations, including delayed elevation, lack of specificity, and variability in sensitivity, especially in neonatal populations. Additional diagnostic tools such as molecular assays (e.g., polymerase chain reaction techniques) have improved the speed of pathogen identification but are not yet universally available. Monocyte distribution width (MDW) is a novel hematological parameter that reflects changes in monocyte size and morphology during inflammatory processes. Monocytes are among the first immune cells to respond to infection, undergoing functional and structural alterations that can be quantitatively assessed through MDW.
- Conditions
- Late Onset Neonatal Sepsis
- Being tested
- MDW measurement
- Keywords
- MDW, LONS
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDW measurementDiagnostic test
Monocyte Distribution Width (MDW), which represents the standard deviation of monocyte cell volume, will be measured at the time of first clinical suspicion of LONS, preferably before the initiation of antibiotic therapy when possible, using 2 mL peripheral venous blood collected in EDTA tubes. Blood samples will be analyzed as soon as possible after collection using an automated hematology analyzer that reports MDW. The result will be recorded as part of the CBC without requiring an additional blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | This group will include 30 preterm neonates with suspected LONS who fulfill the predefined clinical and laboratory criteria of clinical sepsis and/or have positive blood culture Receives: Diagnostic Test: MDW measurement | |
| Control group | It will include 30 neonates evaluated for suspected sepsis who will have negative blood cultures, will not fulfill the predefined clinical sepsis criteria, and will have an alternative non-infectious diagnosis. Receives: Diagnostic Test: MDW measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis
Monocyte distribution width (MDW) will be measured as part of the complete blood count at the time of first clinical suspicion of late-onset neonatal sepsis. Its diagnostic performance for culture-proven late-onset neonatal sepsis will be evaluated using receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: At enrollment, with reference classification based on blood culture results available within approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Late Onset Neonatal SepsisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Khaled Zidan, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821190
- Sponsor's protocol ID
- MDW, LONS
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Wang J, Hu M and Wang N. Combined detection of monocyte distribution width and procalcitonin for diagnosing and prognosing neonatal sepsis. BMC Infect Dis. 2025;25(1):64. 2. Wu J, Li L and Luo J. Diagnostic and prognostic value of monocyte distribution width in sepsis. J Inflamm Res. 2022;20(15):41-63. 3. Coggins SA,Mohan P and Glaser K. Updates in Late-Onset Sepsis: Risk Assessment, Therapy, and Outcomes. Neoreviews. 2022;23(11):738-55. 4. Shah J, Jefferies AL and Yoon EW. Risk Factors and Outcomes of Late-Onset Bacterial Sepsis in Preterm Neonates Born at < 32 Weeks' Gestation. Am J Perinatol. 2015;32(7):675-82. 5. Duignan SM, Lakshminrusimha S, Armstrong K, et al. Neonatal sepsis and cardiovascular dysfunction I: mechanisms and pathophysiology. Pediatr Res. ';95(5):1207-16. 6. Eichberger J, Resch E and Resch B. Diagnosis of neonatal sepsis: the role of inflammatory markers. Front pediatr. 2022;10(8):84-90. 7. Stylianou-Riga P, Boutsikou T, Kouis P, et al. Epidemiology, risk factors, clinical presentation and complications of late-onset neonatal sepsis among preterm neonates in Cyprus: a prospective case-control study. BMC Pediatr. 2024;24(1):50-60. 8. Sands K, Spiller OB and Thomson K. Early-onset neonatal sepsis in low-and middle-income countries: current challenges and future opportunities. Infect Drug Resist. 2022;9(15):933-46. 9. Li J, Xiang L, Chen X, et al. Global, regional, and national burden of neonatal sepsis and other neonatal infections, 1990-2019: findings from the Global Burden of Disease Study 2019. Eur J Pediatr. 2023;182(5):35-43. 10. Bromiker R, Elron E and Klinger G. Do Neonatal Infections Require a Positive Blood Culture? Am J Perinatol. 2020;37(2):18-21. 11. Celik IH, Hanna M and Canpolat FE. Diagnosis of neonatal sepsis: the past, present and future. Pediatr Res. 2022;91(2):337-50. 12. Tum FC, Ngeranwa JJ and Maiyoh GK. Validity of procalcitonin and C-reactive protein as biomarkers in diagnosis of neonatal sepsis in a referral hospital, K
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocyte Distribution Width as a Novel Diagnostic Biomarker in Late-Onset Sepsis Among Preterm Neonates
- ClinicalTrials.gov ID
- NCT07821190
- Acronym / sponsor ID
- MDW, LONS
- Conditions
- Late Onset Neonatal Sepsis
- Keywords
- MDW, LONS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 15 Sep 2026 (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.
This study aims to evaluate the diagnostic accuracy of monocyte distribution width (MDW) as a novel biomarker for late-onset neonatal sepsis in preterm neonates and to assess its association with disease severity and short-term clinical outcomes
Detailed description
Neonatal sepsis is a major cause of morbidity and mortality among newborns worldwide. It represents a systemic inflammatory response to infection that can rapidly progress to severe complications, including multi-organ dysfunction and death. The clinical presentation is often nonspecific, making early diagnosis challenging and frequently delayed. The diagnosis of LOS relies on a combination of clinical suspicion, microbiological confirmation, and supportive laboratory findings. Blood culture remains the gold standard for diagnosis, as it confirms the infection and identifies the causative organism, allowing for targeted antibiotic therapy. Biomarkers play an essential role in the early detection and management of sepsis. Commonly used biomarkers include C-reactive protein (CRP), an indicator of systemic inflammation and infection. However, these markers have limitations, including delayed elevation, lack of specificity, and variability in sensitivity, especially in neonatal populations. Additional diagnostic tools such as molecular assays (e.g., polymerase chain reaction techniques) have improved the speed of pathogen identification but are not yet universally available. Monocyte distribution width (MDW) is a novel hematological parameter that reflects changes in monocyte size and morphology during inflammatory processes. Monocytes are among the first immune cells to respond to infection, undergoing functional and structural alterations that can be quantitatively assessed through MDW.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Diagnostic Test: MDW measurementThis group will include 30 preterm neonates with suspected LONS who fulfill the predefined clinical and laboratory criteria of clinical sepsis and/or have positive blood culture |
| Control group | – | Diagnostic Test: MDW measurementIt will include 30 neonates evaluated for suspected sepsis who will have negative blood cultures, will not fulfill the predefined clinical sepsis criteria, and will have an alternative non-infectious diagnosis. |
Who may qualify
- Ages
- 73 hours to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- A total of 60 preterm neonates with clinical suspicion of late-onset neonatal sepsis (LONS) will be included. All eligible neonates admitted to the Neonatal Intensive Care Unit (NICU) of the Pediatrics Department, Tanta University Hospitals, will be screened, and those meeting the inclusion criteria will be enrolled consecutively at the time of first clinical suspicion of sepsis
Key inclusion criteria (10 listed)
- Preterm neonates with gestational age <37 weeks.
- Neonates aged >72 hours of life at the time of enrollment.
- Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following:
Key exclusion criteria (7 listed)
- Neonates with any of the following will be excluded from the study:
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 |
|---|---|---|
| MDW measurementMonocyte Distribution Width (MDW), which represents the standard deviation of monocyte cell volume, will be measured at the time of first clinical suspicion of LONS, preferably before the initiation of antibiotic therapy when possible, using 2 mL peripheral venous blood collected in EDTA tubes. Blood samples will be analyzed as soon as possible after collection using an automated hematology analyzer that reports MDW. The result will be recorded as part of the CBC without requiring an additional blood sample. | Diagnostic test | Control group, Sepsis group |
Primary outcome
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis
Time frame: At enrollment, with reference classification based on blood culture results available within approximately 5 days
Monocyte distribution width (MDW) will be measured as part of the complete blood count at the time of first clinical suspicion of late-onset neonatal sepsis. Its diagnostic performance for culture-proven late-onset neonatal sepsis will be evaluated using receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value.
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 15 Sep 2026.
- Background1. Wang J, Hu M and Wang N. Combined detection of monocyte distribution width and procalcitonin for diagnosing and prognosing neonatal sepsis. BMC Infect Dis. 2025;25(1):64. 2. Wu J, Li L and Luo J. Diagnostic and prognostic value of monocyte distribution width in sepsis. J Inflamm Res. 2022;20(15):41-63. 3. Coggins SA,Mohan P and Glaser K. Updates in Late-Onset Sepsis: Risk Assessment, Therapy, and Outcomes. Neoreviews. 2022;23(11):738-55. 4. Shah J, Jefferies AL and Yoon EW. Risk Factors and Outcomes of Late-Onset Bacterial Sepsis in Preterm Neonates Born at < 32 Weeks' Gestation. Am J Perinatol. 2015;32(7):675-82. 5. Duignan SM, Lakshminrusimha S, Armstrong K, et al. Neonatal sepsis and cardiovascular dysfunction I: mechanisms and pathophysiology. Pediatr Res. ';95(5):1207-16. 6. Eichberger J, Resch E and Resch B. Diagnosis of neonatal sepsis: the role of inflammatory markers. Front pediatr. 2022;10(8):84-90. 7. Stylianou-Riga P, Boutsikou T, Kouis P, et al. Epidemiology, risk factors, clinical presentation and complications of late-onset neonatal sepsis among preterm neonates in Cyprus: a prospective case-control study. BMC Pediatr. 2024;24(1):50-60. 8. Sands K, Spiller OB and Thomson K. Early-onset neonatal sepsis in low-and middle-income countries: current challenges and future opportunities. Infect Drug Resist. 2022;9(15):933-46. 9. Li J, Xiang L, Chen X, et al. Global, regional, and national burden of neonatal sepsis and other neonatal infections, 1990-2019: findings from the Global Burden of Disease Study 2019. Eur J Pediatr. 2023;182(5):35-43. 10. Bromiker R, Elron E and Klinger G. Do Neonatal Infections Require a Positive Blood Culture? Am J Perinatol. 2020;37(2):18-21. 11. Celik IH, Hanna M and Canpolat FE. Diagnosis of neonatal sepsis: the past, present and future. Pediatr Res. 2022;91(2):337-50. 12. Tum FC, Ngeranwa JJ and Maiyoh GK. Validity of procalcitonin and C-reactive protein as biomarkers in diagnosis of neonatal sepsis in a referral hospital, K
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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.
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 Late Onset Neonatal Sepsis, run by Tanta 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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Lamiaa Khaled Zidan (00201007958439, lamia.kh.z@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Monocyte Distribution Width for Late-Onset Neonatal Sepsis (time frame: At enrollment, with reference classification based on blood culture results available within approximately 5 days). 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 NCT07821190, which also lists 1 linked publication.
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 15 Sep 2026.