Neonatal SepsisNCT07663084
CBC Indices and Serum Lactate in Neonatal Sepsis
An observational study of Neonatal Sepsis and Sepsis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Sepsis, Sepsis
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 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 0 to 28 days
- All sexes
- Child
Study population: 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.
Who may be able to join
- Neonates aged 0 to 28 days (term and preterm).
- Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability [< 36.5°C or > 37.5°C], tachycardia/bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone).
- Informed written consent obtained from the parents or legal guardians.
Who cannot join
- Neonates with severe congenital anomalies or chromosomal abnormalities.
- Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels).
- Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis.
- Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission.
- Neonates who have received prior blood transfusions.
- Neonates requiring immediate surgical intervention.
About this study
Official title: Diagnostic and Prognostic Values of CBC Indices and Serum Lactate in Neonatal Sepsis
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.
Read more
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.
Read the detailed description
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.
- Maternal and perinatal history will be extracted from obstetric records, including details such as maternal age, duration of premature rupture of membranes (PROM), intrapartum fever, maternal urinary tract infections, Group B Streptococcus (GBS) status, and mode of delivery.
- Continuous physiologic monitoring will record heart rate, respiratory rate, and oxygen saturation.
- Core body temperature will be assessed continuously using skin temperature probes.
- An attending neonatologist will conduct a physical examination to document clinical signs of sepsis, including feeding intolerance, abdominal distension, lethargy, hypotonia, apnea, chest retractions, cyanosis, and altered capillary refill time.
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.
- Skin antisepsis will be performed using a two-step technique with 70% isopropyl alcohol followed by 2% chlorhexidine gluconate, which will be allowed to air-dry completely.
- A precise volume of 3.0 to 4.0 mL of peripheral venous blood will be extracted.
- The blood will be distributed in a strict order of draw: 1.0 to 2.0 mL for the pediatric aerobic blood culture bottle, 1.0 mL into a gray-top tube containing Sodium Fluoride and Potassium Oxalate to halt glycolysis for lactate testing, and 1.0 mL into a purple-top K2EDTA tube for the CBC.
Laboratory Analytical Methods:
- CBC parameters will be analyzed using a fully automated, 5-part differential hematology analyzer utilizing flow cytometry and electrical impedance (Coulter principle). Additionally, a manual peripheral blood smear stained with Leishman's stain will be evaluated under a light microscope by a designated clinical pathologist blinded to the patient's clinical status. The pathologist will evaluate for toxic granulation, Döhle bodies, and cytoplasmic vacuolization, and perform a manual 100-cell differential count to calculate the I/T ratio.
- Serum lactate levels will be quantified using a high-throughput automated clinical chemistry analyzer, with photometric measurement at a wavelength of 540 to 550 nm.
- Blood cultures will be loaded into an automated, continuous-monitoring microbial detection system. Bottles will be incubated at 37.0°C and continuously agitated, utilizing sensors to detect carbon dioxide produced by actively metabolizing microorganisms. Negative bottles will be incubated for a full 5 days before being finalized.
- Conditions
- Neonatal Sepsis, Sepsis
- Keywords
- Neonatal Sepsis, Complete Blood Count Indices, Serum Lactate, Mean Platelet Volume, Immature-to-Total Neutrophil Ratio, Red Cell Distribution Width, Diagnostic Biomarkers, Prognosis
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with Suspected Sepsis | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faten Samir Malak Nashed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663084
- Sponsor's protocol ID
- CBC/Lactate in Neonatal Sepsis
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Values of CBC Indices and Serum Lactate in Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT07663084
- Acronym / sponsor ID
- CBC/Lactate in Neonatal Sepsis
- Conditions
- Neonatal Sepsis, Sepsis
- Keywords
- Neonatal Sepsis, Complete Blood Count Indices, Serum Lactate, Mean Platelet Volume, Immature-to-Total Neutrophil Ratio, Red Cell Distribution Width, Diagnostic Biomarkers, Prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jun 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.
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.
Detailed description
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.
- Maternal and perinatal history will be extracted from obstetric records, including details such as maternal age, duration of premature rupture of membranes (PROM), intrapartum fever, maternal urinary tract infections, Group B Streptococcus (GBS) status, and mode of delivery.
- Continuous physiologic monitoring will record heart rate, respiratory rate, and oxygen saturation.
- Core body temperature will be assessed continuously using skin temperature probes.
- An attending neonatologist will conduct a physical examination to document clinical signs of sepsis, including feeding intolerance, abdominal distension, lethargy, hypotonia, apnea, chest retractions, cyanosis, and altered capillary refill time.
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.
- Skin antisepsis will be performed using a two-step technique with 70% isopropyl alcohol followed by 2% chlorhexidine gluconate, which will be allowed to air-dry completely.
- A precise volume of 3.0 to 4.0 mL of peripheral venous blood will be extracted.
- The blood will be distributed in a strict order of draw: 1.0 to 2.0 mL for the pediatric aerobic blood culture bottle, 1.0 mL into a gray-top tube containing Sodium Fluoride and Potassium Oxalate to halt glycolysis for lactate testing, and 1.0 mL into a purple-top K2EDTA tube for the CBC.
Laboratory Analytical Methods:
- CBC parameters will be analyzed using a fully automated, 5-part differential hematology analyzer utilizing flow cytometry and electrical impedance (Coulter principle). Additionally, a manual peripheral blood smear stained with Leishman's stain will be evaluated under a light microscope by a designated clinical pathologist blinded to the patient's clinical status. The pathologist will evaluate for toxic granulation, Döhle bodies, and cytoplasmic vacuolization, and perform a manual 100-cell differential count to calculate the I/T ratio.
- Serum lactate levels will be quantified using a high-throughput automated clinical chemistry analyzer, with photometric measurement at a wavelength of 540 to 550 nm.
- Blood cultures will be loaded into an automated, continuous-monitoring microbial detection system. Bottles will be incubated at 37.0°C and continuously agitated, utilizing sensors to detect carbon dioxide produced by actively metabolizing microorganisms. Negative bottles will be incubated for a full 5 days before being finalized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with Suspected Sepsis | – | –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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- Neonates aged 0 to 28 days (term and preterm).
- Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability [< 36.5°C or > 37.5°C], tachycardia/bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone).
- Informed written consent obtained from the parents or legal guardians.
Key exclusion criteria (6 listed)
- Neonates with severe congenital anomalies or chromosomal abnormalities.
- Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels).
- Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis.
- Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission.
- Neonates who have received prior blood transfusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Immature-to-Total Neutrophil (I/T) Ratio
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
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.
Diagnostic Accuracy of Mean Platelet Volume (MPV)
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
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.
Diagnostic Accuracy of Red Cell Distribution Width (RDW)
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
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.
Diagnostic Accuracy of Admission Serum Lactate Levels
Time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
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.
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 10 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis and Sepsis, run by Assiut University.
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 3 inclusion and 6 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Immature-to-Total Neutrophil (I/T) Ratio (time frame: Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)). The study lists 4 primary outcomes in all. 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 10 Jul 2026.