Profile of Pediatric Patients Admitted to AU ICU

March 25, 2020 updated by: GM Abdelsalam, Assiut University

Profile and Clinical Outcome of Pediatric Patients Admitted to Intensive Care Unit of Assiut University Children Hospital

This study aims to determine the profile and outcome of children admitted to ICU at Assiut University children hospital in order to detect association between risk factors and outcome, to asses the efficacy of treatment making it possible to take better decisions , to improve the quality of care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the PICU whichever is the diagnosis

Description

Inclusion Criteria:

  • all patients admitted to intensive care unit of Assiut University children hospital over one year aged from 1month to 18 years

Exclusion Criteria:

  • pediatric patients less than one month old Pediatric patients will die on arrival

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients according to age groups and gender
Time Frame: 1 year

The demographic data (including age groups and gender).

Regarding age groups, the number of patients in each of three groups will be addressed:

  1. 1 month to 2 years of age
  2. 2 years to 12 years of age
  3. 12 to 18 years of age"

Regarding gender, the number of patients will be allocated in 2 groups:

  1. male
  2. female
1 year
Number of patients according to diagnosis on admission
Time Frame: 1 year
Provisional diagnosis on admission categorised by the system affected (respiratory, cardiovascular, neurological, hematological, renal, endocrinal and metabolic gastrointestinal and hepatobiliary, multi system affection, others (post operative, post arrest, sepsis syndrome, malignancies, poisoning, coma of unknownorigin)). The data will be presented as number of patients in each group of system affected.
1 year
Number of patients according to referral site
Time Frame: 1 year

The patients will be allocated in 2 groups of referral sites of patients admitted to the PICU:

  1. the ward
  2. the emergency department. Data will be presented as number of patients in each group.
1 year
Number of patients according to the need for mechanical ventilation and its duration
Time Frame: 1 year
The patients will be allocated in 2 groups based on the need for mechanical ventilation duringthe PICU stay. In case of need for mechanical ventilation, the duration will be recorded in days.
1 year
Length of stay in days
Time Frame: 1 year
Length of stay in the pediatric intensive care unit (PICU) will be presented as number of days spent by the patient from admission to discharge or death.
1 year
Pediatric Risk of Mortality score on admission
Time Frame: 1 year
Pediatric Risk of Mortlaity (PRISM) III score will be obtained from all patients within the first 24 hours of admission to the PICU. The maximum total PRISM III score is 74. The higher the score, the worse the prognosis. For the analysis of mortality risk factors, patients will be allocated into two groups according to PRISM III 24 score values >8 and ≤ 8, based on previously published data showing increased mortality risk in patients with PRISM III 24 score >8.
1 year
Number of patients according to the condition of discharge from the pediatric intensive care unit
Time Frame: 1 year

Number of patients discharged from the PICU allocated in 2 groups:

  1. improvent and transfer to the corresponding medical ward. (Survivors)
  2. death. N.B. patients who will be discharged against medical advice (DAMA) will be excluded from the proposed data analysis, but will be pointed at.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation 1
Time Frame: 1 year
Correlation between number of patients in discharge groups (survivors / dead) and age group.
1 year
Correlation 2
Time Frame: 1 year
Correlation between number of patients in discharge groups (survivors / dead) and diagnosis on admission.
1 year
Correlation 3
Time Frame: 1 year
Correlation between number of patients in discharge groups (survivors / dead) and length of stay.
1 year
Correlation 4
Time Frame: 1 year
Correlation between number of patients in discharge groups (survivors / dead) and PRISM III score.
1 year
Correlation 5
Time Frame: 1 year
Correlation between number of patients in discharge groups (survivors / dead) and duration of mechanical ventilation.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • gehad011157

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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