CBC Indices and Serum Lactate in Neonatal Sepsis
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.
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Accuracy of Immature-to-Total Neutrophil (I/T) Ratio
Tidsramme: 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.
|
Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
|
|
Diagnostic Accuracy of Mean Platelet Volume (MPV)
Tidsramme: 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.
|
Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
|
|
Diagnostic Accuracy of Red Cell Distribution Width (RDW)
Tidsramme: 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.
|
Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
|
|
Diagnostic Accuracy of Admission Serum Lactate Levels
Tidsramme: 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.
|
Baseline (Upon admission to the NICU, prior to empirical antimicrobial therapy)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CBC/Lactate in Neonatal Sepsis
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .