Pediatric Acute Respiratory Distress Syndrome Asia Study (PARDS Asia)

Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high-end expiratory pressure. A recent retrospective study of ventilation practices in Asia showed varying practices with regards to pulmonary and non-pulmonary therapies, including ventilation. This study aims to determine the prevalence and outcomes of PARDS in the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN). This study will also determine the use of pulmonary (mechanical ventilation, steroids, neuromuscular blockade, surfactant, pulmonary vasodilators, prone positioning) and non-pulmonary (nutrition, sedation, fluid management, transfusion) PARDS therapies. To achieve this aim, a prospective observational study which involves systematic screening of all pediatric intensive care unit (PICU) admissions and collection of pertinent clinical data will be conducted. Recruitment will be consecutive and follow up will continue to intensive care discharge.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation; Pediatric Intensive Care Unit
• Intervention / Treatment: Other: Ventilation protocol

Detailed Description

The overall objective of this study is to prospectively determine the epidemiology of children with PARDS and describe its management in Asia. The first specific aim is to determine the prevalence of PARDS among PICU admissions. This will be achieved by establishing a systematic manner of screening patients and including them in this study. The second specific aim is to describe the use of pulmonary and non-pulmonary therapies in PARDS. This study will utilize an established dataset to extract pertinent and analyzable clinical data.The third specific aim is to determine the outcome of patients with PARDS. These outcomes will include functional data, PICU mortality, ventilator duration and length of stay data. This is a two-part study - the first part to establish the baseline prevalence and ventilator management strategies, the second part will include the implementation of an evidence based ventilation protocol as part of routine care. The same screening process, eligibility criteria and data collection will apply throughout the two parts. We aim to obtain data for approximately 2years prior to and 2years subsequent to the implementation of the ventilator protocol.

• Study Type: Observational
• Enrollment (Actual): 738

Contacts and Locations

• Study Contact: Name: Judith Ju Ming Wong; Phone Number: +6592355980 +6592355980; Email: judith.wong.jm@singhealth.com.sg
• Study Contact Backup: Name: Cecilia Chandra; Phone Number: 63941616; Email: cecilia.a.chandra@kkh.com.sg

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Guangzhou Women and Children's Medical Center
  • Liaoning
    • Shenyang, Liaoning, China
      • ShengJing Hospital Of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Children's Hospital of Fudan University
  • Sichuan
    • Chongqing, Sichuan, China
      • Chongqing Hospital
• Hong Kong
  • Kowloon
    • Kowloon Bay, Kowloon, Hong Kong
      • Hong Kong Children's Hospital
• India
  • Chandigarh, India
    • Post Graduate Institute of Medical Education and Research
• Indonesia
  • Jakarta, Indonesia
    • Harapan Kita Children and Women hospital
  • Bali
    • Denpasar, Bali, Indonesia
      • Sanglah Hospital Denpasar
• Japan
  • Kobe
    • Hyōgo, Kobe, Japan
      • Hyogo prefectural Kobe Children's Hospital
• Malaysia
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
  • Kuala Lumpur
    • Bandar Tun Razak, Kuala Lumpur, Malaysia
      • Universiti Kebangsaan Malaysia Medical Centre
  • Sarawak
    • Kuching, Sarawak, Malaysia
      • Sarawak General Hospital
• Pakistan
  • Karachi, Pakistan
    • Aga Khan University Hospital
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore
    • National University Hospital, Singapore
• Thailand
  • Bangkok, Thailand
    • Ramathibodi Hospital
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand
      • Siriraj Hospital
• Vietnam
  • Hanoi
    • Dong Da, Hanoi, Vietnam
      • National Hospital of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All PICU admission will be screened daily and those who meet the PALICC criteria for PARDS will be recruited and consented (if necessary). We will include those on non-invasive ventilation and alternative modes of ventilation. However, a minimum positive end expiratory pressure of 5cmH2O is necessary for inclusion, as per PALICC. Patients with any type of cardiorespiratory comorbidity will also be included if they fulfill the PALICC criteria for special populations (cyanotic heart disease, chronic lung disease and left ventricular failure). Patients who have limitation of care (i.e. do-not-resuscitate orders) or develop brainstem death will also be included to enable calculation of prevalence.

Description

Inclusion Criteria:

• Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS

Exclusion Criteria:

• Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
• High flow nasal cannula

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of PARDS	Number of participants diagnosed with PARDS over number of intensive care admissions	Through study completion
Mortality	Number of PARDS participants who died over number of participants diagnosed with PARDS	up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days	Number of days alive and free of mechanical ventilation	up to 28 days
Intensive Care Unit free days	Number of days alive and discharge from the intensive care unit	up to 28 days
Extracorporeal membrane oxygenation	Number of participants who require ECMO	up to 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite mortality and ECMO	Number of PARDS participants who died or required ECMO over total number of participants diagnosed with PARDS	up to 60 days
Sensitivity analysis	Mortality and secondary outcomes excluding limitation of care orders	up to 60 days

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: National University Hospital, Singapore; University of Malaya; Aga Khan University; Ramathibodi Hospital; Shengjing Hospital; Universiti Kebangsaan Malaysia Medical Centre; Children's Hospital of Fudan University; King Chulalongkorn Memorial Hospital; Post Graduate Institute of Medical Education and Research, Chandigarh; National Children's Hospital, Vietnam; Guangzhou Women and Children's Medical Center; Singapore Clinical Research Institute; Children's Hospital of Chongqing Medical University; Hong Kong Children's Hospital; Siriraj Hospital; Sarawak General Hospital; Hyogo Prefectural Kobe Children's Hospital; Rumah Sakit Anak dan Bunda Harapan Kita; Sanglah General Hospital; General Hospital of North Sumatera University
• Investigators: Principal Investigator: Judith Ju Ming Wong, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2017/3076(2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing will depend on ethics approval of individual sites

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No