NCT06481644

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

Study Progress52%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 8, 2026

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

June 25, 2024

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    ICU mortality and time based mortality

    Including 28-days and 60-days

Secondary Outcomes (6)

  • Ventilator duration

    Including 28-days and 60-days

  • ICU duration

    Including 28-days and 60-days

  • Nosocomial infections

    Throughout ICU stay including 28-days and 60-days

  • Accidental extubations

    Throughout ICU stay including 28-days and 60-days

  • Line associated thrombosis

    Throughout ICU stay including 28-days and 60-days

  • +1 more secondary outcomes

Other Outcomes (2)

  • Resource utilisation

    Throughout ICU stay including 28-days and 60-days

  • Cardiopulmonary resuscitation

    Throughout ICU stay including 28-days and 60-days

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients admitted to the pediatric ICUs of participant hospitals

You may not qualify if:

  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

K K Women's and Children's Hospital

Singapore, Singapore

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, deep tracheal lavage, bronchoalveoalr lavage, respiratory and oropharyngeal swabs, surface swabs, stools.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith Ju Ming Wong

    K K Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Ju Ming Wong, MBBCh BAO

CONTACT

Cecilia Chandran

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 8, 2026

Record last verified: 2025-08

Locations