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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

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

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

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

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.

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.

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)

April 1, 2020

Primary Completion (ANTICIPATED)

March 30, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID 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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