An observational study in Neonatal Sepsis and Sepsis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Assiut University · Observational
Among 13 studies in Neonatal Sepsis by Assiut University — 4 open to participants now, 4 under way, none of them phase 3. Neonatal Sepsis · Assiut University.
Among the 13 studies in Neonatal Sepsis by Assiut University, this one is the 8th largest by planned enrollment of the 12 observational ones that give a count, is one of 2 that started in 2026, is one of 12 observational ones, and was the 13th registered.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
Browse Neonatal Sepsis studies →4 of the 13 studies in Neonatal Sepsis by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Assiut University
Assiut University
By country, each count listing its studies:
Of the 23 Neonatal Sepsis studies recruiting now, 8 (35%) set no upper age limit and 15 (65%) stop at 75 or younger; 20 take children under 18; 2 take healthy volunteers.
This study: 0 Days to 28 Days · all sexes.
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13 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 80 is below the median of 200 across 85 observational studies indexed under Neonatal Sepsis.
Median enrollment 100 across the 1 interventional studies, 100 across the 12 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Neonatal Sepsis by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07663084Assiut UniversityCBC Indices and Serum Lactate in Neonatal Sepsis | 2027-08 |
Among the 13 studies in Neonatal Sepsis by Assiut University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Neonatal sepsis is a leading cause of illness and death in Neonatal Intensive Care Units (NICUs). Diagnosing it quickly is challenging because the early signs often overlap with other common newborn health issues. While a blood culture is the most accurate way to confirm an infection, the results can take 48 to 72 hours. This delay highlights the need for faster, more accessible diagnostic tools.
This observational study aims to find quicker ways to diagnose neonatal sepsis and predict its severity using readily available blood tests. Researchers are investigating whether specific details from a standard Complete Blood Count (CBC), such as the variation in red blood cell size (RDW), the average size of platelets (MPV), and the ratio of immature to total white blood cells (I/T ratio), combined with serum lactate levels (a marker of tissue oxygenation and stress) can serve as reliable, early warning signs.
The study will enroll newborns (0 to 28 days old) admitted to the NICU who show clinical signs of a possible infection. Upon admission and before starting any antibiotic treatment, a small blood sample will be drawn to measure these CBC indices and serum lactate, alongside the standard blood culture.
By comparing these rapid blood test results with the final blood culture outcomes and the infants' overall clinical progress in the NICU, the research team hopes to determine if this simple combination of markers can help doctors diagnose sepsis earlier, anticipate the severity of the illness, and make faster, life-saving treatment decisions.
Neonatal sepsis remains one of the most devastating conditions encountered in neonatal intensive care units (NICUs) worldwide. The global population-level incidence of neonatal sepsis is estimated at approximately 2,202 cases per 100,000 live births, with mortality ranging between 11% and 19%. Diagnosis is clinically challenging because signs are nonspecific and overlap with other neonatal conditions. Although blood culture is the gold standard for diagnosis, it has significant limitations, including a 48 to 72-hour delay for results, low sensitivity due to the small blood volumes collected from neonates, and the risk of contamination. Complete blood count (CBC) indices, including the absolute neutrophil count, immature-to-total neutrophil (I/T) ratio, mean platelet volume (MPV), and red cell distribution width (RDW), have attracted interest as accessible screening tools. Furthermore, serum lactate is an established critical prognostic biomarker that reflects tissue hypoperfusion and anaerobic metabolism. This study aims to evaluate the combined diagnostic and prognostic values of these CBC-derived indices and serum lactate in a resource-limited NICU environment.
Upon admission to the NICU, every enrolled neonate will undergo a comprehensive clinical assessment.
To prevent pre-analytical errors and sample contamination, a strict aseptic blood sampling protocol will be executed prior to the administration of any empirical antimicrobial therapy.
Laboratory Analytical Methods:
The study population will consist of term and preterm neonates, aged 0 to 28 days, who are admitted to the Neonatal Intensive Care Unit (NICU) at the Pediatrics Department of Assiut University Children Hospitals in Assiut, Egypt. Eligible participants must present with two or more clinical signs highly suggestive of sepsis, such as temperature instability, tachycardia or bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone. Neonates with severe congenital anomalies, chromosomal abnormalities, inborn errors of metabolism, severe perinatal asphyxia, or those who have received prior broad-spectrum intravenous antibiotics for more than 24 hours, prior blood transfusions, or require immediate surgical intervention will not be included in the study.
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Exclusion Criteria:
This cohort includes term and preterm neonates aged 0 to 28 days admitted to the Neonatal Intensive Care Unit (NICU) presenting with two or more clinical signs highly suggestive of sepsis (e.g., temperature instability, tachycardia/bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone). Upon admission and prior to the administration of any empirical antimicrobial therapy, peripheral venous blood samples will be drawn to evaluate Complete Blood Count (CBC) indices, quantify serum lactate levels, and perform a blood culture. As this is an observational study, no experimental interventions or medications will be administered to this group.
Diagnostic Accuracy of Immature-to-Total Neutrophil (I/T) Ratio
he diagnostic accuracy (including Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve) of the initial Immature-to-Total Neutrophil (I/T) ratio in distinguishing between culture-proven sepsis, clinical sepsis, and non-septic neonates.
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
Diagnostic Accuracy of Mean Platelet Volume (MPV)
The diagnostic accuracy (including Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve) of the initial Mean Platelet Volume (MPV) in distinguishing between culture-proven sepsis, clinical sepsis, and non-septic neonates.
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
Diagnostic Accuracy of Red Cell Distribution Width (RDW)
The diagnostic accuracy (including Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve) of the initial Red Cell Distribution Width (RDW) in distinguishing between culture-proven sepsis, clinical sepsis, and non-septic neonates.
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
Diagnostic Accuracy of Admission Serum Lactate Levels
The diagnostic accuracy (including Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve) of initial serum lactate levels in distinguishing between culture-proven sepsis, clinical sepsis, and non-septic neonates.
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 37 non-industry observational studies under Neonatal Sepsis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 38 studies reached it within 25 months; a quarter within 16 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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