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NCT Number: NCT07279675

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Assessment of Pneumonia Severity

Other

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

Primary outcomes

  1. Association of Severity Scores with Clinical Outcomes

    Time frame: 14 days from enrollment (typical hospital stay and outpatient follow-up)

    The primary outcome will be the correlation coefficient (r value) between the Community-Acquired Pneumonia (CAP) severity score and each clinical outcome.

    The clinical outcomes will include:

    Length of hospital stay (days) Oxygen requirement (L/min) ICU admission (yes/no) Occurrence of complications (yes/no) Mortality (yes/no)

  2. Severity of Community-Acquired Pneumonia Assessed by the Respiratory Index of Severity in Children (RISC)

    Time frame: 4 days from enrollment (typical hospital stay and outpatient follow-up)

    CAP severity will be assessed using the Respiratory Index of Severity in Children (RISC) score.

    The RISC score ranges from 0 to 6, with higher scores indicating more severe disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Mohamed Hassan, resident

CONTACT

[email protected]

01004231328

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: CAP-Severity

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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