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Asia Pediatric Intensive Care Epidemiology and Outcomes Study

Asia Pediatric Intensive Care Epidemiology and Outcomes Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06481644
Acronym
AsiaPedIC
Enrollment
10000
Registered
2024-07-01
Start date
2024-08-01
Completion date
2027-12-31
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care Unit, Pediatrics

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 (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.

Interventions

None listed

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV
King Chulalongkorn Memorial Hospital
CollaboratorOTHER
Tengku Ampuan Rahimah Hospital
CollaboratorOTHER_GOV
King Abdullah Specialized Children's Hospital
CollaboratorUNKNOWN
Children's Hospital 2
CollaboratorUNKNOWN
University Malaysia Medical Centre
CollaboratorUNKNOWN
Saiful Anwar Hospital
CollaboratorOTHER
Murni Teguh Memorial Hospital
CollaboratorUNKNOWN
Siriraj Hospital
CollaboratorOTHER
Harapan Kita Women and Children Hospital
CollaboratorOTHER
Vicente Sotto Memorial Medical Center
CollaboratorUNKNOWN
Hong Kong Children's Hospital
CollaboratorOTHER
Ramathibodi Hospital
CollaboratorOTHER
Aga Khan University
CollaboratorOTHER
Aichi Children's Health and Medical Center, Japan
CollaboratorUNKNOWN
Hospital Sultanah Aminah Johor Bahru
CollaboratorOTHER_GOV
Children's Hospital of Chongqing Medical University
CollaboratorOTHER
Prof IGNG Ngoerah Hospital
CollaboratorUNKNOWN
Penang Hospital, Malaysia
CollaboratorOTHER_GOV
Vietnam National Children's Hospital
CollaboratorUNKNOWN
Hospital Pakar Kanak-kanak UKM
CollaboratorUNKNOWN
National University Hospital, Singapore
CollaboratorOTHER
Queen Elizabeth Hospital, Hong Kong
CollaboratorOTHER
Shanghai Children's Medical Center
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients admitted to the pediatric ICUs of participant hospitals

Exclusion criteria

* No consent

Design outcomes

Primary

MeasureTime frameDescription
MortalityIncluding 28-days and 60-daysICU mortality and time based mortality

Secondary

MeasureTime frameDescription
Ventilator durationIncluding 28-days and 60-daysVentilator duration and ventilator free days to account for mortality as competing outcome
ICU durationIncluding 28-days and 60-daysICU duration and ICU free days to account for mortality as competing outcome
Nosocomial infectionsThroughout ICU stay including 28-days and 60-daysIncluding catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia
Accidental extubationsThroughout ICU stay including 28-days and 60-daysUnplanned extubations
Line associated thrombosisThroughout ICU stay including 28-days and 60-daysIncluding venous or arterial clots related or unrelated to the presence of invasive catheters
Unplanned ICU readmissionsIncluding readmissions within 24hourNon-elective ICU readmissions

Countries

Singapore, Thailand

Contacts

CONTACTJudith Ju Ming Wong, MBBCh BAO
judith.wong.jm@singhealth.com.sg92355980
CONTACTCecilia Chandran
Research@kkh.com.sg
PRINCIPAL_INVESTIGATORJudith Ju Ming Wong

K K Women's and Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026