PediatricsAsiaPedICNCT06481644
Asia Pediatric Intensive Care Epidemiology and Outcomes Study
An observational study of Pediatrics and Intensive Care Unit, run by KK Women's and Children's Hospital at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatrics, Intensive Care Unit, Critical Illness
- How many people
- 10,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients admitted to the pediatric ICUs of participant hospitals
Who cannot join
- No consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Cecilia Chandran contact
2 sites in 2 countries
Singapore1 site, 1 recruiting
- Recruiting
K K Women's and Children's Hospital
Singapore
Judith Wong, judith.wong.jm@singhealth.com.sg
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok
Kritsaporn Sujjavorakul, k.sujjavorakul@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pediatrics, Intensive Care Unit, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mortality
ICU mortality and time based mortality
Measured: Including 28-days and 60-days
Secondary outcomes (6)
Ventilator duration
Ventilator duration and ventilator free days to account for mortality as competing outcome
Measured: Including 28-days and 60-days
ICU duration
ICU duration and ICU free days to account for mortality as competing outcome
Measured: Including 28-days and 60-days
Nosocomial infections
Including catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia
Measured: Throughout ICU stay including 28-days and 60-days
Accidental extubations
Unplanned extubations
Measured: 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
Measured: Throughout ICU stay including 28-days and 60-days
Unplanned ICU readmissions
Non-elective ICU readmissions
Measured: Including readmissions within 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- King Chulalongkorn Memorial Hospital, Tengku Ampuan Rahimah Hospital, King Abdullah Specialized Children's Hospital, Children's Hospital 2, University of Malaya, Saiful Anwar Hospital, Murni Teguh Memorial Hospital, Siriraj Hospital, Harapan Kita Women and Children Hospital, Vicente Sotto Memorial Medical Center, Hong Kong Children's Hospital, Ramathibodi Hospital, Aga Khan University, Aichi Children's Health and Medical Center, Japan, Hospital Sultanah Aminah Johor Bahru, Children's Hospital of Chongqing Medical University, Prof IGNG Ngoerah Hospital, Penang Hospital, Malaysia, National Children's Hospital, Vietnam, Hospital Pakar Kanak-kanak UKM, National University Hospital, Singapore, Queen Elizabeth Hospital, Hong Kong, Shanghai Children's Medical Center
- Responsible party
- Principal investigator, Judith Wong Ju-Ming, KK Women's and Children's Hospital
- Investigators
- Judith Ju Ming Wong, Principal investigator, K K Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481644
- Sponsor's protocol ID
- 2015/2231
- Acronym
- AsiaPedIC
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asia Pediatric Intensive Care Epidemiology and Outcomes Study
- ClinicalTrials.gov ID
- NCT06481644
- Acronym / sponsor ID
- AsiaPedIC / 2015/2231
- Conditions
- Pediatrics, Intensive Care Unit, Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- King Chulalongkorn Memorial Hospital, Tengku Ampuan Rahimah Hospital, King Abdullah Specialized Children's Hospital, Children's Hospital 2, University of Malaya, Saiful Anwar Hospital, Murni Teguh Memorial Hospital, Siriraj Hospital, Harapan Kita Women and Children Hospital, Vicente Sotto Memorial Medical Center, Hong Kong Children's Hospital, Ramathibodi Hospital, Aga Khan University, Aichi Children's Health and Medical Center, Japan, Hospital Sultanah Aminah Johor Bahru, Children's Hospital of Chongqing Medical University, Prof IGNG Ngoerah Hospital, Penang Hospital, Malaysia, National Children's Hospital, Vietnam, Hospital Pakar Kanak-kanak UKM, National University Hospital, Singapore, Queen Elizabeth Hospital, Hong Kong, Shanghai Children's Medical Center
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients admitted to the pediatric ICUs of participant hospitals
Key exclusion criteria (1 listed)
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Including 28-days and 60-days
ICU mortality and time based mortality
6 secondary outcomes
Ventilator duration
Time frame: Including 28-days and 60-days
ICU duration
Time frame: Including 28-days and 60-days
Nosocomial infections
Time frame: Throughout ICU stay including 28-days and 60-days
Accidental extubations
Time frame: Throughout ICU stay including 28-days and 60-days
Line associated thrombosis
Time frame: Throughout ICU stay including 28-days and 60-days
Unplanned ICU readmissions
Time frame: Including readmissions within 24hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cecilia Chandran contact
Judith Ju Ming Wong principal investigator
K K Women's and Children's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Intensive Care Unit, run by KK Women's and Children's Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Ju Ming Wong, MBBCh BAO (92355980, judith.wong.jm@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Including 28-days and 60-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.