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Pediatric Acute Respiratory Distress Syndrome Asia Study (PARDSProASIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068038
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Judith Wong Ju-Ming, KK Women's and Children's Hospital

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
Acute Respiratory Distress Syndrome Pediatric Intensive Care Unit Mechanical Ventilation

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 established the baseline prevalence and ventilator management strategies, the second part (to be registered separately) will include the intervention of a ventilation protocol.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2023





Primary Outcome Measures :
  1. Prevalence of PARDS [ Time Frame: Through study completion ]
    Number of participants diagnosed with PARDS over number of intensive care admissions

  2. Mortality [ Time Frame: up to 60 days ]
    Number of PARDS participants who died over number of participants diagnosed with PARDS


Secondary Outcome Measures :
  1. Ventilator free days [ Time Frame: up to 28 days ]
    Number of days alive and free of mechanical ventilation

  2. Intensive Care Unit free days [ Time Frame: up to 28 days ]
    Number of days alive and discharge from the intensive care unit

  3. Extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
    Number of participants who require ECMO


Other Outcome Measures:
  1. Composite mortality and ECMO [ Time Frame: up to 60 days ]
    Number of PARDS participants who died or required ECMO over total number of participants diagnosed with PARDS


Biospecimen Retention:   Samples With DNA
Respiratory fluid Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068038


Contacts
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Contact: Judith Ju Ming Wong +6592355980 ext +6592355980 judith.wong.jm@singhealth.com.sg
Contact: Cecilia Chandra 63941616 cecilia.a.chandra@kkh.com.sg

Locations
Show Show 19 study locations
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
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Principal Investigator: Judith Ju Ming Wong KK Women's and Children's Hospital
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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: August 28, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing will depend on ethics approval of individual sites

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury