- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324177
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
Intervention / Treatment
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:
Regarding gender, the number of patients will be allocated in 2 groups:
|
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 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 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.
Sponsor
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
- Haftu H, Hailu T, Medhaniye A, G/Tsadik T. Assessment of pattern and treatment outcome of patients admitted to pediatric intensive care unit, Ayder Referral Hospital, Tigray, Ethiopia, 2015. BMC Res Notes. 2018 May 24;11(1):339. doi: 10.1186/s13104-018-3432-4.
- Khilnani P, Sarma D, Singh R, Uttam R, Rajdev S, Makkar A, Kaur J. Demographic profile and outcome analysis of a tertiary level pediatric intensive care unit. Indian J Pediatr. 2004 Jul;71(7):587-91. doi: 10.1007/BF02724117.
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
Additional Relevant MeSH Terms
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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