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

NCT ID: NCT07279675

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Detailed Description

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.

Conditions

Community-Acquired Pneumonia; Pediatric Pneumonia; Lower Respiratory Tract Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Children With Community-Acquired Pneumonia

This cohort includes all children aged 1 month to 5 years diagnosed with community-acquired pneumonia (CAP) who present to the pediatric emergency department or are admitted to the pediatric wards of Assiut University Children Hospital during the study period (October 2025 - October 2026).

All participants will undergo systematic assessment of severity using clinical predictors, laboratory tests, radiological imaging, and the Respiratory Index of Severity in Children (RISC) score.

Assessment of Pneumonia Severity

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Mohamed Sayed Hassan

Resident, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Esraa Mohamed Hassan, resident

Role: CONTACT

esraamhassaan7@gmail.com

01004231328

References

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.

Reference Type: BACKGROUND

PMID: 40036666 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35727140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36791115 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

AUC-PEDE-CAP-2025

Identifier Type: -

Identifier Source: org_study_id