Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481644
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
Asia Pediatric Intensive Care Epidemiology and Outcomes Study
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Asia Pediatric Intensive Care Epidemiology and Outcomes Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AsiaPedIC
Brief Summary:
The overall objective of this study is to improve the standard of care of critically ill pediatric patients The specific aims are to describe the clinical profile and outcomes of all admissions to Asian pediatric ICUs determine the risk factors associated with poor outcomes determine quality indicators for benchmarking ICU performance across sites and develop and train artificial intelligence algorithms to predict mortality length of ICU stay and resource utilization
Detailed Description:
Critical illness is associated with high mortality and morbidity The mortality rate in pediatric ICUs globally may vary from 2 in high resource settings to a 28 in low resource settings This variable mortality outcome is due to several factors There are differing patient populations eg medical surgical oncology who get admitted to the ICU and at different severity thresholds Patients in the region are ethnically and genetically diverse And lastly ICU management itself is variable and dependent on expertise and resources This study will adopt a multicentered prospective observational design Data on patient demographics clinical characteristics ICU therapies ICU quality indicators and outcomes will be recorded prospectively Statistical analysis will include descriptive statistics multivariable analysis area under the receiver operating curve analysis and a variety of machine learning algorithms to achieve its aims
Though the main methodology is recruitment of all pediatric ICU admissions a pre-determined random sampling protocol is allowed for sites with limited in resources for recruitment and data collection This protocol may involve recruitment of all admissions for 1year 52 weeks all admissions for 1 month per quarter over 1 year 16 weeks all admissions for 1 week per month over 1 year 12 weeks all admissions for 2 weeks per quarter over 1 year 8 weeks or all admissions for 1 week for quarter over 1 year 4 weeks - this will be declared at the start of the study by each participating site before recruitment begins This strategy will allow us to include sites with and without sufficient resources to be represented in this study As ethics approval will take time each site may enter the study at differing time points and recruit for 1 year Patients who have previously consented under the Singapore Pediatric Intensive Care Registry SG-PedIC under a similar single-center pilot study protocol which started from 2020 may be included In the statistical analysis random down sampling may be performed to avoid over-representation from high recruitment sites
A planned subgroup study will be conducted for patients with and without pediatric chronic complex conditions PCCC PCCC represent a significant and growing subset of patients admitted to PICU Although PCCCs make up only 10 to 17 of pediatric hospital admissions they account for more than 50 of PICU admissions and use more than 75 of PICU resources These conditions often involve multi-system involvement and prolonged hospitalizations leading to substantial healthcare resource utilization and posing considerable challenges for clinical management Understanding the characteristics outcomes and risk factors associated with these patients is crucial for improving clinical care and resource allocation In this subgroup study we will characterise patients with PCCCs determine outcomes and identify risk factors for poor outcomes
Though the main methodology is recruitment of all pediatric ICU admissions a pre-determined random sampling protocol is allowed for sites with limited in resources for recruitment and data collection This protocol may involve recruitment of all admissions for 1year 52 weeks all admissions for 1 month per quarter over 1 year 16 weeks all admissions for 1 week per month over 1 year 12 weeks all admissions for 2 weeks per quarter over 1 year 8 weeks or all admissions for 1 week for quarter over 1 year 4 weeks - this will be declared at the start of the study by each participating site before recruitment begins This strategy will allow us to include sites with and without sufficient resources to be represented in this study As ethics approval will take time each site may enter the study at differing time points and recruit for 1 year Patients who have previously consented under the Singapore Pediatric Intensive Care Registry SG-PedIC under a similar single-center pilot study protocol which started from 2020 may be included In the statistical analysis random down sampling may be performed to avoid over-representation from high recruitment sites
A planned subgroup study will be conducted for patients with and without pediatric chronic complex conditions PCCC PCCC represent a significant and growing subset of patients admitted to PICU Although PCCCs make up only 10 to 17 of pediatric hospital admissions they account for more than 50 of PICU admissions and use more than 75 of PICU resources These conditions often involve multi-system involvement and prolonged hospitalizations leading to substantial healthcare resource utilization and posing considerable challenges for clinical management Understanding the characteristics outcomes and risk factors associated with these patients is crucial for improving clinical care and resource allocation In this subgroup study we will characterise patients with PCCCs determine outcomes and identify risk factors for poor outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None