Critical IllnessNCT07858487
pSOFA Score in Predicting Mortality in Pediatric Intensive Care
An observational study of Critical Illness and Multiple Organ Dysfunction Syndrome, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Critical Illness, Multiple Organ Dysfunction Syndrome
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Pediatric Sequential Organ Failure Assessment (pSOFA) Score in Predicting Mortality and Outcome in Pediatric Intensive Care Unit
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.
Read the detailed description
Critical illness in children may progress to dysfunction of one or more organ systems, and multiple organ dysfunction is an important determinant of morbidity and mortality. The Pediatric Sequential Organ Failure Assessment (pSOFA) score evaluates six organ systems (respiratory, cardiovascular, neurological, hepatic, coagulation, and renal) in critically ill children, with each domain scored from 0 to 4 and a total score of 0-24.
This prospective observational cohort study will include 100 critically ill children admitted to the PICU of Assiut University Children's Hospital who fulfill the eligibility criteria. Demographic, clinical, and laboratory data required for pSOFA calculation will be collected. The worst value for each variable during each 24-hour period will be used to calculate the score. The primary outcome will be in-hospital mortality; secondary outcomes will include PICU length of stay, mechanical ventilation duration, vasoactive support, MODS, hospital length of stay, and renal replacement therapy.
- Keywords
- pSOFA score, Pediatric intensive care, Organ dysfunction, Mortality, MODS, Assiut
- Medical subject headings
- Critical Illness, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Mortality
Proportion of critically ill children who die during hospital stay, assessed by review of medical records and PICU follow-up.
Measured: Up to 4 weeks
Secondary outcomes (6)
PICU Length of Stay
Mean number of days spent in the Pediatric Intensive Care Unit (PICU), assessed by review of medical records.
Measured: Up to 4 weeks
Duration of Mechanical Ventilation
Mean number of days of mechanical ventilation, assessed by review of medical records.
Measured: Up to 4 weeks
Need for Vasoactive Support
Proportion of children requiring vasoactive medications during PICU stay, assessed by review of medical records.
Measured: Up to 4 weeks
Multiple Organ Dysfunction Syndrome (MODS)
Proportion of children who develop multiple organ dysfunction syndrome (MODS) during PICU stay, assessed by review of medical records.
Measured: Up to 4 weeks
Hospital Length of Stay
Mean number of days spent in the hospital, assessed by review of medical records.
Measured: Up to 8 weeks
Need for Renal Replacement Therapy
Proportion of children requiring renal replacement therapy during PICU stay, assessed by review of medical records.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hussen, Assiut University
- Investigators
- Emad M Hammad, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858487
- Sponsor's protocol ID
- pSOFA-PICU-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pediatric Sequential Organ Failure Assessment (pSOFA) Score in Predicting Mortality and Outcome in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07858487
- Acronym / sponsor ID
- pSOFA-PICU-Assiut-2026
- Keywords
- pSOFA score, Pediatric intensive care, Organ dysfunction, Mortality, MODS, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Critical illness in children may progress to dysfunction of one or more organ systems, and multiple organ dysfunction is an important determinant of morbidity and mortality. The Pediatric Sequential Organ Failure Assessment (pSOFA) score evaluates six organ systems (respiratory, cardiovascular, neurological, hepatic, coagulation, and renal) in critically ill children, with each domain scored from 0 to 4 and a total score of 0-24.
This prospective observational cohort study will include 100 critically ill children admitted to the PICU of Assiut University Children's Hospital who fulfill the eligibility criteria. Demographic, clinical, and laboratory data required for pSOFA calculation will be collected. The worst value for each variable during each 24-hour period will be used to calculate the score. The primary outcome will be in-hospital mortality; secondary outcomes will include PICU length of stay, mechanical ventilation duration, vasoactive support, MODS, hospital length of stay, and renal replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-Hospital Mortality
Time frame: Up to 4 weeks
Proportion of critically ill children who die during hospital stay, assessed by review of medical records and PICU follow-up.
6 secondary outcomes
PICU Length of Stay
Time frame: Up to 4 weeks
Duration of Mechanical Ventilation
Time frame: Up to 4 weeks
Need for Vasoactive Support
Time frame: Up to 4 weeks
Multiple Organ Dysfunction Syndrome (MODS)
Time frame: Up to 4 weeks
Hospital Length of Stay
Time frame: Up to 8 weeks
Need for Renal Replacement Therapy
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emad M Hammad, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Multiple Organ Dysfunction Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara H Abdellatif, Resident (+20 10 95752600, Sara.17289692@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Mortality (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.