NCT07279675

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

November 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 27, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

Community-acquired pneumoniaClinical risk factorsHypoxemia

Outcome Measures

Primary Outcomes (2)

  • Association of Severity Scores with Clinical Outcomes

    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)

    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)

    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.

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

Study Arms (1)

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.

Other: Assessment of Pneumonia Severity

Interventions

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

Children With Community-Acquired Pneumonia

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1 month to 5 years of both sexes diagnosed with community-acquired pneumonia (CAP) presenting to the pediatric emergency department or admitted to pediatric wards at Assiut University Children's Hospital during the study period (October 2025 - October 2026). Children with hospital-acquired pneumonia, known immunodeficiency, chronic respiratory diseases, or congenital lung malformations are excluded.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 40036666BACKGROUND
  • 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: 35727140BACKGROUND
  • 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: 36791115BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Community-Acquired PneumoniaHypoxia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esraa Mohamed Hassan, resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Pediatrics

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 12, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share