CBC Indices and Serum Lactate in Neonatal Sepsis

Sponsor
Assiut University
Study ID
NCT07663084
Status
Not Yet Recruiting

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Conditions

  • Neonatal Sepsis
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
0 Days - 28 Days
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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.

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) ]

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