NCT04324177

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 19, 2020

Last Update Submit

March 25, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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. 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

    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

    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

    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

    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

    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

    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 Outcomes (5)

  • Correlation 1

    1 year

  • Correlation 2

    1 year

  • Correlation 3

    1 year

  • Correlation 4

    1 year

  • Correlation 5

    1 year

Interventions

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the PICU whichever is the diagnosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 29793551BACKGROUND
  • 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.

    PMID: 15280607BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Demography

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Gehad Mahmoud Abdelsalam

CONTACT

Mohammed M. Hamdy Ghazaly

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 27, 2020

Study Start

April 1, 2020

Primary Completion

March 30, 2021

Study Completion

May 1, 2021

Last Updated

March 27, 2020

Record last verified: 2020-03