PARDSProASIA: Pediatric Acute Respiratory Distress Syndrome Asia Study

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04068038
Collaborator
Children's Hospital of Chongqing Medical University (Other), Guangzhou Women and Children's Medical Center (Other), Shengjing Hospital (Other), Children's Hospital of Fudan University (Other), Hong Kong Children's Hospital (Other), Sarawak General Hospital (Other), Universiti Kebangsaan Malaysia Medical Centre (Other), University of Malaya (Other), King Chulalongkorn Memorial Hospital (Other), Siriraj Hospital (Other), Ramathibodi Hospital (Other), National Children's Hospital, Vietnam (Other), Postgraduate Institute of Medical Education and Research, Chandigarh (Other), Rumah Sakit Anak dan Bunda Harapan Kita (Other), Sanglah General Hospital (Other), General Hospital of North Sumatera University (Other), Hyogo Prefectural Kobe Children's Hospital (Other), Aga Khan University (Other), National University Hospital, Singapore (Other), Singapore Clinical Research Institute (Other)
800
19
48
42.1
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 2years prior to and 2years subsequent to the implementation of the ventilator protocol.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Prevalence of PARDS [Through study completion]

    Number of participants diagnosed with PARDS over number of intensive care admissions

  2. Mortality [up to 60 days]

    Number of PARDS participants who died over number of participants diagnosed with PARDS

Secondary Outcome Measures

  1. Ventilator free days [up to 28 days]

    Number of days alive and free of mechanical ventilation

  2. Intensive Care Unit free days [up to 28 days]

    Number of days alive and discharge from the intensive care unit

  3. Extracorporeal membrane oxygenation [up to 28 days]

    Number of participants who require ECMO

Other Outcome Measures

  1. Composite mortality and ECMO [up to 60 days]

    Number of PARDS participants who died or required ECMO over total number of participants diagnosed with PARDS

  2. Sensitivity analysis [up to 60 days]

    Mortality and secondary outcomes excluding limitation of care orders

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangzhou Women and Children's Medical Center Guangzhou Guangzhou China
2 Shengjing hospital of China Medical University Shenyang Liaoning China
3 Children's Hospital of Fudan University Shanghai Shanghai China
4 Chongqing Hospital Chongqing Sichuan China
5 Hong Kong Children's Hospital Kowloon Bay Kowloon Hong Kong
6 Post Graduate Institute of Medical Education and Research Chandigarh India
7 Sanglah Hospital Denpasar Denpasar Bali Indonesia
8 Harapan Kita Children and Women hospital Jakarta Indonesia
9 Hyogo Prefectural Kobe Children's Hospital Hyōgo Kobe Japan
10 Universiti Kebangsaan Malaysia Medical Centre Bandar Tun Razak Kuala Lumpur Malaysia
11 Sarawak General Hospital Kuching Sarawak Malaysia
12 University Malaya Medical Centre Kuala Lumpur Malaysia
13 Aga Khan University Hospital Karachi Pakistan
14 KK Women's and Children's Hospital Singapore Singapore 229899
15 National University Hospital, Singapore Singapore Singapore
16 Siriraj Hospital Bangkok Noi Bangkok Thailand
17 King Chulalongkorn Memorial Hospital Bangkok Thailand
18 Ramathibodi hospital Bangkok Thailand
19 National Hospital of Pediatrics Dong Da Hanoi Vietnam

Sponsors and Collaborators

  • KK Women's and Children's Hospital
  • Children's Hospital of Chongqing Medical University
  • Guangzhou Women and Children's Medical Center
  • Shengjing Hospital
  • Children's Hospital of Fudan University
  • Hong Kong Children's Hospital
  • Sarawak General Hospital
  • Universiti Kebangsaan Malaysia Medical Centre
  • University of Malaya
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital
  • Ramathibodi Hospital
  • National Children's Hospital, Vietnam
  • Postgraduate Institute of Medical Education and Research, Chandigarh
  • Rumah Sakit Anak dan Bunda Harapan Kita
  • Sanglah General Hospital
  • General Hospital of North Sumatera University
  • Hyogo Prefectural Kobe Children's Hospital
  • Aga Khan University
  • National University Hospital, Singapore
  • Singapore Clinical Research Institute

Investigators

  • Principal Investigator: Judith Ju Ming Wong, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith Wong Ju-Ming, Consultant Pediatric Critical Care, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT04068038
Other Study ID Numbers:
  • 2017/3076(2)
First Posted:
Aug 28, 2019
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022