Profile of Pediatric Patients Admitted to AU ICU

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04324177
• Other study ID #: gehad011157
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Gehad Mahmoud Abdelsalam
• Phone: +201091294596
• Email: gehad011157[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2021
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Demographic data, morbidity data
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	Correlation 1	Correlation between number of patients in discharge groups (survivors / dead) and age group.	1 year
Secondary	Correlation 2	Correlation between number of patients in discharge groups (survivors / dead) and diagnosis on admission.	1 year
Secondary	Correlation 3	Correlation between number of patients in discharge groups (survivors / dead) and length of stay.	1 year
Secondary	Correlation 4	Correlation between number of patients in discharge groups (survivors / dead) and PRISM III score.	1 year
Secondary	Correlation 5	Correlation between number of patients in discharge groups (survivors / dead) and duration of mechanical ventilation.	1 year