pSOFA Score in Predicting Mortality in Pediatric Intensive Care

NCT07858487 | Not Yet Recruiting

• 1 other identifier: pSOFA-PICU-Assiut-2026
• Study Type: observational
• Target: 121
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational cohort study aims to evaluate the predictive performance of the Pediatric Sequential Organ Failure Assessment (pSOFA) score for mortality and selected clinical outcomes among critically ill children admitted to the Pediatric Intensive Care Unit (PICU). A total of 100 children will be enrolled and followed during their PICU stay.

Conditions

Critical Illness; Multiple Organ Dysfunction Syndrome

Keywords

pSOFA score; Pediatric intensive care; Organ dysfunction; Mortality; MODS; Assiut

Outcome Measures

Primary Outcomes (1)

• In-Hospital Mortality

  Proportion of critically ill children who die during hospital stay, assessed by review of medical records and PICU follow-up.

  Up to 4 weeks

Secondary Outcomes (6)

• PICU Length of Stay

  Up to 4 weeks

• Duration of Mechanical Ventilation

  Up to 4 weeks

• Need for Vasoactive Support

  Up to 4 weeks

• Multiple Organ Dysfunction Syndrome (MODS)

  Up to 4 weeks

• Hospital Length of Stay

  Up to 8 weeks

Study Arms (1)

Critically Ill Children Admitted to PICU

Consecutive critically ill children aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit (PICU) of Assiut University Children's Hospital who fulfill the eligibility criteria and will be followed to assess pSOFA score and clinical outcomes.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill children aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit (PICU) of Assiut University Children's Hospital who fulfill the eligibility criteria.

You may qualify if:

• Age 1 month to 18 years.
• PICU admission requiring intensive monitoring and/or organ support.
• Availability of required pSOFA clinical and laboratory data.
• Written informed consent from parent/legal guardian.

You may not qualify if:

• Age less than 1 month.
• PICU stay less than 24 hours.
• Incomplete data required for pSOFA calculation.
• Readmission during the same hospitalization.
• Refusal by parent/legal guardian.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Critical Illness; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Emad M Hammad, prof

  Pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Sara H Abdellatif, Resident

CONTACT

+20 10 95752600; Sara.17289692@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Pediatrics

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 5, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share