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Набор скоро начнётся NCT07279675

Clinical Predictors of Severity in Pediatric Community-Acquired Pneumonia at Assiut University Children's Hospital

Наблюдательное Community-Acquired Pneumonia Pediatric Pneumonia Lower Respiratory Tract Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessment of Pneumonia Severity.
Кому может быть актуально
Состояния в реестре: Community-Acquired Pneumonia, Pediatric Pneumonia, Lower Respiratory Tract Infection. Базовые параметры: 1 мес. — 5 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study aims to identify the clinical factors that predict the severity of community-acquired pneumonia (CAP) in pediatric patients. Children admitted to Assiut University Children's Hospital with a diagnosis of CAP will be evaluated through clinical examination, vital signs, laboratory investigations, and radiological findings. The study focuses on determining which clinical features are associated with more severe disease, higher need for oxygen therapy, intensive care admission, or complications. Understanding these predictors may help clinicians recognize severe cases earlier and improve patient management and outcomes.

Подробное описание

Community-acquired pneumonia (CAP) is one of the most common causes of morbidity and hospitalization among children worldwide. Early recognition of severe cases is essential for timely intervention. However, clinical predictors of severity in pediatric CAP vary across populations, and there is a need for locally applicable evidence to guide clinical decision-making.

This observational cross-sectional study will enroll pediatric patients presenting with community-acquired pneumonia to Assiut University Children's Hospital. The diagnosis of CAP will be established based on clinical assessment and radiological confirmation. For each patient, demographic data, presenting symptoms, physical examination findings, vital signs, laboratory investigations, and radiological features will be recorded systematically according to the study protocol.

The primary objective of this study is to identify the clinical and laboratory predictors that are significantly associated with severe pneumonia. Severity will be assessed based on predefined criteria, including oxygen requirement, respiratory distress indicators, complications, and need for intensive care admission. Secondary objectives include describing the distribution of severity levels among the enrolled patients and assessing the relationship between individual risk factors and disease outcomes.

The results of this study are expected to provide clinically relevant predictors that can support early identification of severe CAP in children, improve triage decisions, and optimize treatment strategies within similar healthcare settings.

Вмешательства

  • Другое Assessment of Pneumonia Severity
    Participants undergo structured evaluation for pneumonia severity, including: Clinical predictors (respiratory rate, chest indrawing, hypoxemia, feeding difficulty, mental status, comorbidities) Laboratory markers (complete blood count, RDW, CRP, HCO₃-) Radiological assessment (chest X-ray, CT if indicated) Calculation of RISC score

Первичные конечные точки

  • Association of Severity Scores with Clinical Outcomes [Срок оценки: 14 days from enrollment (typical hospital stay and outpatient follow-up)]
  • Severity of Community-Acquired Pneumonia Assessed by the Respiratory Index of Severity in Children (RISC) [Срок оценки: 4 days from enrollment (typical hospital stay and outpatient follow-up)]

Критерии участия

Критерии включения

  • Children aged 1 month to 5 years.
  • Children of both sexes
  • Onset of illness in the community, not more than 48 hours after hospital admission.

Критерии исключения

  • Children below 1 month, as neonatal pneumonia differs in pathology and management from CAP.
  • Children with hospital-acquired pneumonia
  • Known primary or secondary immunodeficiency
  • Children with chronic respiratory diseases (as cystic fibrosis, bronchiectasis) or congenital lung malformations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Serin O, Akbasli IT, Cetin SB, Koseoglu B, Deveci AF, Ugur MZ, Ozsurekci Y. Predicting Escalation of Care for Childhood Pneumonia Using Machine Learning: Retrospective Analysis and Model Development. JMIRx Med. 2025 Mar 4;6:e57719. doi: 10.2196/57719. PMID 40036666
  • Kapoor A, Awasthi S, Kumar Yadav K. Predicting Mortality and Use of RISC Scoring System in Hospitalized Under-Five Children Due to WHO Defined Severe Community Acquired Pneumonia. J Trop Pediatr. 2022 Jun 6;68(4):fmac050. doi: 10.1093/tropej/fmac050. PMID 35727140
  • Anteneh ZA, Arega HE, Mihretie KM. Validation of risk prediction for outcomes of severe community-acquired pneumonia among under-five children in Amhara region, Northwest Ethiopia. PLoS One. 2023 Feb 15;18(2):e0281209. doi: 10.1371/journal.pone.0281209. eCollection 2023. PMID 36791115
  • O. Shukla, N. Rathwa, and L. Mude, "Assessment of severity of community acquired pneumonia by paediatric infectious diseases society and clinical and radiological profile in 0-5 year age group," 2024, Accessed: Sep. 17, 2025.

Идентификаторы

NCT: NCT07279675 · AUC-PEDE-CAP-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗