CBC Indices and Serum Lactate in Neonatal Sepsis

NCT07663084 | Not Yet Recruiting

• 1 other identifier: CBC/Lactate in Neonatal Sepsis
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)

Study Arms (1)

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.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07