Asia Pediatric Intensive Care Epidemiology and Outcomes Study (AsiaPedIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Intensive Care Unit; Pediatrics

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 (e.g. 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. Existing PICU severity scores (including but not limited to the PIM3, PRISM3/4, PELOD2, PSS, pSOFA) will be evaluated and if necessary, new variables/scores developed which perform better in the regional setting.

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Judith Ju Ming Wong, MBBCh BAO; Phone Number: 92355980; Email: judith.wong.jm@singhealth.com.sg
• Study Contact Backup: Name: Cecilia Chandran; Email: Research@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • K K Women's and Children's Hospital
    • Contact: Judith Wong; Email: judith.wong.jm@singhealth.com.sg
• Thailand
  • Bangkok, Thailand
    • Recruiting
    • King Chulalongkorn Memorial Hospital
    • Contact: Kritsaporn Sujjavorakul; Email: k.sujjavorakul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• All patients admitted to the pediatric ICUs of participant hospitals

Exclusion Criteria:

• No consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric critical illness; All admissions to the pediatric ICU of participant hospitals without restriction to age, gender or race/ethnicity. Patients who have previously consented under the Singapore Pediatric Intensive Care Registry (SG-PedIC) under a similar single-center study protocol which started from 2020 will also be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	ICU mortality and time based mortality	Including 28-days and 60-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator duration	Ventilator duration and ventilator free days to account for mortality as competing outcome	Including 28-days and 60-days
ICU duration	ICU duration and ICU free days to account for mortality as competing outcome	Including 28-days and 60-days
Nosocomial infections	Including catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia	Throughout ICU stay including 28-days and 60-days
Accidental extubations	Unplanned extubations	Throughout ICU stay including 28-days and 60-days
Line associated thrombosis	Including venous or arterial clots related or unrelated to the presence of invasive catheters	Throughout ICU stay including 28-days and 60-days
Unplanned ICU readmissions	Non-elective ICU readmissions	Including readmissions within 24hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilisation	Including ICU bed, ventilator and other ICU support utilisation. Hospital costs.	Throughout ICU stay including 28-days and 60-days
Cardiopulmonary resuscitation	CPR or code blue activation within the ICU	Throughout ICU stay including 28-days and 60-days

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: National University Hospital, Singapore; Aga Khan University; Ramathibodi Hospital; Queen Elizabeth Hospital, Hong Kong; Shanghai Children's Medical Center; King Chulalongkorn Memorial Hospital; Children's Hospital of Chongqing Medical University; Hong Kong Children's Hospital; Siriraj Hospital; Penang Hospital, Malaysia; Hospital Sultanah Aminah Johor Bahru; Saiful Anwar Hospital; Aichi Children's Health and Medical Center, Japan; Vicente Sotto Memorial Medical Center; Tengku Ampuan Rahimah Hospital; King Abdullah Specialized Children's Hospital; Children's Hospital 2; University Malaysia Medical Centre; Murni Teguh Memorial Hospital; Harapan Kita Women and Children Hospital; Prof IGNG Ngoerah Hospital; Vietnam National Children's Hospital; Hospital Pakar Kanak-kanak UKM
• Investigators: Principal Investigator: Judith Ju Ming Wong, K K Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: 2015/2231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At study completion, data may be shared with other researchers provided patients had consented for use of data for future research and requestor obtains ethics approval and data sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No