Critical IllnessNCT04324177
Profile of Pediatric Patients Admitted to AU ICU
An observational study of Critical Illness, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Demographic data, morbidity data
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child, Adult
Study population: All patients admitted to the PICU whichever is the diagnosis
Who may be able to join
- all patients admitted to intensive care unit of Assiut University children hospital over one year aged from 1month to 18 years
Who cannot join
- pediatric patients less than one month old Pediatric patients will die on arrival
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Critical Illness
- Being tested
- Demographic data, morbidity data
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographic data, morbidity dataOther
To detect association between the demographic data of pediatric patients including age ,sex,hospital stay and clinical data including the diagnosis and co morbidity with the outcome of pediatric patients admitted to ICU of Assiut University children hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients according to age groups and gender
The demographic data (including age groups and gender).
Regarding age groups, the number of patients in each of three groups will be addressed:
- 1 month to 2 years of age
- 2 years to 12 years of age
- 12 to 18 years of age"
Regarding gender, the number of patients will be allocated in 2 groups:
- male
- female
Measured: 1 year
Number of patients according to diagnosis on admission
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.
Measured: 1 year
Number of patients according to referral site
The patients will be allocated in 2 groups of referral sites of patients admitted to the PICU:
- the ward
- the emergency department. Data will be presented as number of patients in each group.
Measured: 1 year
Number of patients according to the need for mechanical ventilation and its duration
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.
Measured: 1 year
Length of stay in days
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.
Measured: 1 year
Pediatric Risk of Mortality score on admission
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.
Measured: 1 year
Number of patients according to the condition of discharge from the pediatric intensive care unit
Number of patients discharged from the PICU allocated in 2 groups:
- improvent and transfer to the corresponding medical ward. (Survivors)
- 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.
Measured: 1 year
Secondary outcomes (5)
Correlation 1
Correlation between number of patients in discharge groups (survivors / dead) and age group.
Measured: 1 year
Correlation 2
Correlation between number of patients in discharge groups (survivors / dead) and diagnosis on admission.
Measured: 1 year
Correlation 3
Correlation between number of patients in discharge groups (survivors / dead) and length of stay.
Measured: 1 year
Correlation 4
Correlation between number of patients in discharge groups (survivors / dead) and PRISM III score.
Measured: 1 year
Correlation 5
Correlation between number of patients in discharge groups (survivors / dead) and duration of mechanical ventilation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GM Abdelsalam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324177
- Sponsor's protocol ID
- gehad011157
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29793551Khilnani 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.
PubMed 15280607
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile and Clinical Outcome of Pediatric Patients Admitted to Intensive Care Unit of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04324177
- Acronym / sponsor ID
- gehad011157
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 27 Mar 2020 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All patients admitted to the PICU whichever is the diagnosis
Key inclusion criteria (1 listed)
- all patients admitted to intensive care unit of Assiut University children hospital over one year aged from 1month to 18 years
Key exclusion criteria (1 listed)
- pediatric patients less than one month old Pediatric patients will die on arrival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographic data, morbidity dataTo detect association between the demographic data of pediatric patients including age ,sex,hospital stay and clinical data including the diagnosis and co morbidity with the outcome of pediatric patients admitted to ICU of Assiut University children hospital | Other | – |
Primary outcome
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
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Correlation 1
Time frame: 1 year
Correlation 2
Time frame: 1 year
Correlation 3
Time frame: 1 year
Correlation 4
Time frame: 1 year
Correlation 5
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 29793551Haftu 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.
- Background: PubMed 15280607Khilnani 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.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehad Mahmoud Abdelsalam (+201091294596, gehad011157@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients according to age groups and gender (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324177, which also lists 2 linked publications.
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 27 Mar 2020.