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Late-Onset Neonatal Sepsis: A Case-Control Study (Sepsis)

4 июня 2026 г. обновлено: Aysen Orman, Mersin University

Evaluation of Traditional Biomarkers and Novel Inflammatory Indices in the Diagnosis of Late-Onset Neonatal Sepsis: A Case-Control Study

The diagnosis of late-onset sepsis in term neonates has been studied less than that of early-onset sepsis. Procalcitonin (PCT) and C-reactive protein (CRP) are commonly used biomarkers in the diagnosis of sepsis. However, their diagnostic advantage for late-onset sepsis (GNS) is debatable. Rapid and accurate diagnosis of late-onset infection in newborn infants remains a significant goal in clinical practice worldwide. Therefore, the accuracy of diagnostic tests needs to be improved. This study aimed to evaluate the effectiveness of serum biomarkers in the diagnosis and treatment monitoring of late neonatal sepsis (LOS) in term neonates.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Early diagnosis and detection of LOS are challenging due to its often nonspecific symptoms and the limited diagnostic efficacy of commonly used biomarkers. Therefore, a combined evaluation of clinical and laboratory findings is necessary. While initial assessment often includes nonspecific tests such as complete blood count and inflammatory markers, the most important test is a blood culture of at least 1 mL of blood before antibiotic administration.Although acute phase reactants such as C-reactive protein (CRP), procalcitonin (PCT), and various interleukins are used to support the diagnosis of sepsis in newborns, they are also elevated by other non-infectious inflammatory causes (fetal hypoxia, birth stress, RDS, MAS, IVH, surgery, and pneumothorax). Serum CRP could be a useful biomarker for LOS in newborn infants if it can be demonstrated to have acceptable levels of accuracy. Currently, the role of serum CRP in diagnostic algorithms for late-onset infection is largely varied in the absence of robust evidence to inform the development of guidelines or protocols. Further studies have shown that the immature/total neutrophil ratio and absolute neutrophil values are poor predictors of LOS. Due to age-specific, gestational age-dependent, and neonatal physiological changes in the early postpartum period, there is no consensus on the threshold value of serum PCT levels in bacterial infection.Common laboratory markers of infection, such as white blood cell count (WBC), immature neutrophil/total neutrophil ratio (IT ratio), hematological tests (thrombocytopenia), and acute phase reactants (CRP, PCT), do not have sufficient specificity and sensitivity to detect all infected newborns.Literature analysis has shown that, despite extensive research, the diagnosis and antibiotic treatment of neonatal sepsis cannot currently be determined based on a single biomarker. However, instead of searching for new biomarkers, testing combinations of two or more of the currently available biomarkers seems easier and more productive. The literature has focused primarily on the diagnosis of LOS in preterm neonates. Our current study differs from previous studies in that it evaluates the systemic inflammation aggregate index (SIAI) and systemic inflammation index (SII) values serially, in addition to classical biomarkers. Our aim is to identify a practical combination of commonly used laboratory tests that can evaluate the diagnosis and monitoring of term LOS when suspected.

Тип исследования

Наблюдательный

Регистрация (Действительный)

128

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Да

Метод выборки

Вероятностная выборка

Исследуемая популяция

The study was conducted with two groups: term patients (38-42 weeks' gestation) and controls. The control group was selected to match the sepsis group as closely as possible (at a 1:1 ratio) in terms of demographic characteristics, and taking gestational age into account

Описание

Inclusion Criteria:

  • Term newborn
  • Late-onset neonatal sepsis

Exclusion Criteria:

  • Preterm newborn
  • Major congenital anomaly
  • Congenital metabolic disease
  • Hemolytic anemia
  • Hematological diseases
  • Congenital leukemia
  • Dyserythropoietic anemia
  • Early-onset neonatal sepsis

Control group

  • Neonatal jaundice (indirect hyperbilirubinemia)
  • Transient neonatal tachypnea
  • Early neonatal sepsis

Exclusion criteria Perinatal asphyxia, Meconium aspiration syndrome Polycythemia İntraventricular hemoragy Pneumothorax Hemolytic Anemia

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Patient group 1 control group 2
The control group was selected to match the sepsis group as closely as possible (at a 1:1 ratio) in terms of demographic characteristics and taking gestational age into account
Диагностический тест: serum biomarker
that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy. SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes
control group and patient group

Neonates born before the 38th week of pregnancy, with major congenital anomaly or congenital metabolic disease, babies born to substance-dependent mothers, with hemolytic anemia or other hematological diseases (such as congenital leukemia, dyserythropoetic anemia, or severe hemolytic diseases), and babies diagnosed with immunodeficiency, with early-onset sepsis, with histories of surgery, or with deficient laboratory data were excluded. All babies diagnosed with LOS and meeting none of the exclusion criteria were enrolled and constituted the LOS cohort. In case of more than one LOS episode, only the first was included in the analysis.

Babies with neonatal jaundice (indirect hyperbillurubinemia) of non-hemolytic causes that resolved with phototherapy alone, with transient neonatal tachypnea resolving within the first 24 hours and with no sepsis attack, and infants with non-infectious causes admitted to the NICU were included in the control group. Exclusion criteria for the control gr
Диагностический тест: serum biomarker
that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy. SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Primary outcome measure
Временное ограничение: From July 2020 to July 2024

Immature granulocyte (IG) percentage, the neutrophil/lymphocyte ratio (NLR), CRP, PCT, SIAI, and SII values were recorded from retrospective file data on the first day, that of diagnosis of sepsis, and on the third and seventh days after the commencement of antibiotic therapy. SII was calculated using the formula (neutrophils×platelets)/lymphocytes, and SIAI using neutrophils×monocytes×platelets / lymphocytes.

Diagnostic performance was assessed using receiver operating characteristic (ROC) curve analysis. This study aimed to evaluate the diagnostic performance of commonly used and novel inflammatory biomarkers, both individually and in combination, focusing on their temporal dynamics.

The performance of diagnostic biomarkers (CRP, PCT, IG, SII, and SIAI) was evaluated using receiver operating characteristic (ROC) curve analysis. For each biomarker, the area under the curve (AUC), sensitivity, specificity, and positive and negative predictive values (PPV and NPV) were planned to be c
From July 2020 to July 2024
practical and effective biomarker combination consisting of widely available laboratory tests capable of being used in the diagnosis and monitoring of LOS in term neonates.
Временное ограничение: From July 2020 to July 2024
Term late onset sepsis diagnosis
From July 2020 to July 2024
Diagnostic efficacy of biomarkers in late neonatal sepsis
Временное ограничение: Baseline and 3, 7-day serum biomarker
LOS was defined as onset of sepsis symptoms after the 72nd hour (third day). LOS resulted in respiratory symptoms (apnea, tachypnea, desaturation, and increasing mechanical ventilator support requirements), hemodynamic symptoms (bradycardia, skin color changes, decreased peripheral perfusion, hypotension and cardiovascular impairment, and inotropic therapy requirements), metabolic abnormalities (hypoglycemia, hyperglycemia, or metabolic acidosis abnormalities), body temperature irregularities (hypo or hyperthermia), feeding intolerance, and neurological symptoms (hypotonia, poor sucking, and low neurological activity) . Sepsis was evaluated using complete blood count, CRP, PCT, and blood culture. In line with our routine clinical protocol, specimens were collected from neonates with sepsis before the initiation of antibiotic therapy.
Baseline and 3, 7-day serum biomarker

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Mersin University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 июля 2020 г.

Первичное завершение (Действительный)

1 июля 2024 г.

Завершение исследования (Действительный)

1 июля 2025 г.

Даты регистрации исследования

Первый отправленный

21 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

4 июня 2026 г.

Первый опубликованный (Действительный)

9 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • Mersin University Neonatology

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Special sensitive population

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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