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NCT Number: NCT06481644

Asia Pediatric Intensive Care Epidemiology and Outcomes 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

K K Women's and Children's Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients admitted to the pediatric ICUs of participant hospitals

Exclusion criteria

  • No consent

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Including 28-days and 60-days

    ICU mortality and time based mortality

Secondary outcomes

  1. Ventilator duration

    Time frame: Including 28-days and 60-days

    Ventilator duration and ventilator free days to account for mortality as competing outcome

  2. ICU duration

    Time frame: Including 28-days and 60-days

    ICU duration and ICU free days to account for mortality as competing outcome

  3. Nosocomial infections

    Time frame: Throughout ICU stay including 28-days and 60-days

    Including catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia

  4. Accidental extubations

    Time frame: Throughout ICU stay including 28-days and 60-days

    Unplanned extubations

  5. Line associated thrombosis

    Time frame: Throughout ICU stay including 28-days and 60-days

    Including venous or arterial clots related or unrelated to the presence of invasive catheters

  6. Unplanned ICU readmissions

    Time frame: Including readmissions within 24hour

    Non-elective ICU readmissions

Other outcomes

  1. Resource utilisation

    Time frame: Throughout ICU stay including 28-days and 60-days

    Including ICU bed, ventilator and other ICU support utilisation. Hospital costs.

  2. Cardiopulmonary resuscitation

    Time frame: Throughout ICU stay including 28-days and 60-days

    CPR or code blue activation within the ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Chandran

CONTACT

[email protected]

Judith Ju Ming Wong, MBBCh BAO

CONTACT

[email protected]

92355980

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

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

Registry information

Acronym: AsiaPedIC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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