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Pediatric Acute Respiratory Distress Syndrome Asia Study (PARDSProASIA)

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ClinicalTrials.gov Identifier: NCT04068038
Recruitment Status : Recruiting
First Posted : August 26, 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 Hospital
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

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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
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China, Guangzhou
Guangzhou Women and Children's Medical Center Not yet recruiting
Guangzhou, Guangzhou, China
Contact: Li Huang       huangli7525@163.com   
China, Liaoning
Shengjing hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China
Contact: Chunfeng Liu       liucf@sj-hospital.org   
China, Shanghai
Children's Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China
Contact: Xuemei Zhu       zhuxuemei083@163.com   
China, Sichuan
Chongqing Hospital Recruiting
Chongqing, Sichuan, China
Contact: Hongxing Dang       dhxdoc@163.com   
Hong Kong
Hong Kong Children's Hospital Not yet recruiting
Kowloon Bay, Kowloon, Hong Kong
Contact: Karen Ka Yan Leung       karenleung223@gmail.com   
India
Post Graduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, India
Contact: Muralidharan Jayashree       mjshree@hotmail.com   
Indonesia
Sanglah Hospital Denpasar Not yet recruiting
Denpasar, Bali, Indonesia
Contact: Dyah Kanya Wati       dyahpediatric@yahoo.com   
Harapan Kita Children and Women hospital Not yet recruiting
Jakarta, Indonesia
Contact: Felix Liauw       felixliauw@gmail.com   
Japan
Hyogo Prefectural Kobe Children's Hospital Not yet recruiting
Hyōgo, Kobe, Japan
Contact: Hiroshi Kurosawa       kurosawa@me.com   
Malaysia
Universiti Kebangsaan Malaysia Medical Centre Not yet recruiting
Bandar Tun Razak, Kuala Lumpur, Malaysia
Contact: Chian Wern Tai       chianwern@gmail.com   
Sarawak General Hospital Not yet recruiting
Kuching, Sarawak, Malaysia
Contact: Louise Ngu       louisengu@gmail.com   
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia
Contact: Chin Seng Gan       csgan@ummc.edu.my   
Pakistan
Aga Khan University Hospital Not yet recruiting
Karachi, Pakistan
Contact: Qalab Abbas       qalababbas@gmail.com   
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Judith Wong, MBBCh BAO    +6592355980    judith.wong.jm@singhealth.com.sg   
National University Hospital, Singapore Not yet recruiting
Singapore, Singapore
Contact: Jacqueline Soo May Ong       jacqueline_ong@nuhs.edu.sg   
Thailand
Siriraj Hospital Not yet recruiting
Bangkok Noi, Bangkok, Thailand
Contact: Suwannee Phumeetham       swn_nee@yahoo.com   
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand
Contact: Rujipat Samransamruajkit       rujipatrs@gmail.com   
Ramathibodi hospital Not yet recruiting
Bangkok, Thailand
Contact: Nattachai Anantasit       nattachai032@gmail.com   
Vietnam
National Hospital of Pediatrics Not yet recruiting
Dong Da, Hanoi, Vietnam
Contact: Huu Phan Phuc       phuc.h.phan@nhp.org.vn   
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 Hospital
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     History of Changes
Other Study ID Numbers: 2017/3076(2)
First Posted: August 26, 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
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury