Asia Pediatric Intensive Care Epidemiology and Outcomes Study

NCT ID: NCT06481644

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Pediatrics Intensive Care Unit Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to the pediatric ICUs of participant hospitals

Exclusion Criteria

* No consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role collaborator

Tengku Ampuan Rahimah Hospital

OTHER_GOV

Sponsor Role collaborator

King Abdullah Specialized Children's Hospital

UNKNOWN

Sponsor Role collaborator

Children's Hospital 2

UNKNOWN

Sponsor Role collaborator

University Malaysia Medical Centre

UNKNOWN

Sponsor Role collaborator

Saiful Anwar Hospital

OTHER

Sponsor Role collaborator

Murni Teguh Memorial Hospital

UNKNOWN

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role collaborator

Harapan Kita Women and Children Hospital

OTHER

Sponsor Role collaborator

Vicente Sotto Memorial Medical Center

UNKNOWN

Sponsor Role collaborator

Hong Kong Children's Hospital

OTHER

Sponsor Role collaborator

Ramathibodi Hospital

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role collaborator

Aichi Children's Health and Medical Center, Japan

UNKNOWN

Sponsor Role collaborator

Hospital Sultanah Aminah Johor Bahru

OTHER_GOV

Sponsor Role collaborator

Children's hospital of Chonqing Medical University

UNKNOWN

Sponsor Role collaborator

Prof IGNG Ngoerah Hospital

UNKNOWN

Sponsor Role collaborator

Penang Hospital, Malaysia

OTHER_GOV

Sponsor Role collaborator

Vietnam National Children's Hospital

UNKNOWN

Sponsor Role collaborator

Hospital Pakar Kanak-kanak UKM

UNKNOWN

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Judith Wong Ju-Ming

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Ju Ming Wong

Role: PRINCIPAL_INVESTIGATOR

K K Women's and Children's Hospital

Locations

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K K Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Singapore Thailand

Central Contacts

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Judith Ju Ming Wong, MBBCh BAO

Role: CONTACT

Cecilia Chandran

Role: CONTACT

Facility Contacts

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Judith Wong

Role: primary

Kritsaporn Sujjavorakul

Role: primary

Other Identifiers

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2015/2231

Identifier Type: -

Identifier Source: org_study_id

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