Acute Respiratory Distress SyndromePARDS AsiaNCT04068038
Pediatric Acute Respiratory Distress Syndrome Asia Study
An observational study of Acute Respiratory Distress Syndrome and Pediatric Intensive Care Unit, run by KK Women's and Children's Hospital at 19 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Pediatric Intensive Care Unit, Mechanical Ventilation
- What is being tested?
- Ventilation protocol
- How many people
- 738 participants
- Where
- 19 sitesin 10 countries
- Study dates
- 1 Aug 2019to 7 Jul 2024
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS
Who cannot join
- Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
- High flow nasal cannula
Trial locations and contacts
19 sites in 10 countries.
19 sites in 10 countries
China4 sites
Chongqing Hospital
Chongqing, Sichuan
Guangzhou Women and Children's Medical Center
Guangzhou, Guangzhou
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Shengjing hospital of China Medical University
Shenyang, Liaoning
Malaysia3 sites
Universiti Kebangsaan Malaysia Medical Centre
Bandar Tun Razak, Kuala Lumpur
University Malaya Medical Centre
Kuala Lumpur
Sarawak General Hospital
Kuching, Sarawak
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok
Ramathibodi hospital
Bangkok
Siriraj Hospital
Bangkok Noi, Bangkok
Indonesia2 sites
Sanglah Hospital Denpasar
Denpasar, Bali
Harapan Kita Children and Women hospital
Jakarta
Singapore2 sites
KK Women's and Children's Hospital
Singapore, 229899
National University Hospital, Singapore
Singapore
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome, Pediatric Intensive Care Unit, Mechanical Ventilation
- Being tested
- Ventilation protocol
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation protocolOther
An evidence based ventilation protocol will be implemented at participating sites. This will include limits on peak inspiratory pressure (28cmH2O), driving pressure (16cmH2O), tidal volume (mild 8ml/kg, mod/severe 6ml/kg), positive end expiratory pressure to fraction of inspired oxygen table, permissive hypercarbia (mild allow pH 7.30, mod/severe allow pH 7.20) and permissive hypoxia (mild SpO2 92-97%, mod/severe SpO2 88-92%).
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PARDS
Number of participants diagnosed with PARDS over number of intensive care admissions
Measured: Through study completion
Mortality
Number of PARDS participants who died over number of participants diagnosed with PARDS
Measured: up to 60 days
Secondary outcomes (3)
Ventilator free days
Number of days alive and free of mechanical ventilation
Measured: up to 28 days
Intensive Care Unit free days
Number of days alive and discharge from the intensive care unit
Measured: up to 28 days
Extracorporeal membrane oxygenation
Number of participants who require ECMO
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Mar 2023
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- 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, Post Graduate Institute of Medical Education and Research, Chandigarh, Rumah Sakit Anak dan Bunda Harapan Kita, RSUP Prof. Dr. I.G.N.G. Ngoerahal, General Hospital of North Sumatera University, Hyogo Prefectural Kobe Children's Hospital, Aga Khan University, National University Hospital, Singapore, Singapore Clinical Research Institute
- Responsible party
- Principal investigator, Judith Wong Ju-Ming, KK Women's and Children's Hospital
- Investigators
- Judith Ju Ming Wong, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068038
- Sponsor's protocol ID
- 2017/3076(2)
- Acronym
- PARDS Asia
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2019
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing will depend on ethics approval of individual sites
Publications
Wong JJM, Dang H, Gan CS, Phan PH, Kurosawa H, Aoki K, Lee SW, Ong JSM, Fan LJ, Tai CW, Chuah SL, Lee PC, Chor YK, Ngu L, Anantasit N, Liu C, Xu W, Wati DK, Gede SIB, Jayashree M, Liauw F, Pon KM, Huang L, Chong JY, Zhu X, Hon KLE, Leung KKY, Samransamruajkit R, Cheung YB, Lee JH; Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN). Lung-Protective Ventilation for Pediatric Acute Respiratory Distress Syndrome: A Nonrandomized Controlled Trial. Crit Care Med. 2024 Oct 1;52(10):1602-1611. doi: 10.1097/CCM.0000000000006357. Epub 2024 Jun 26.
PubMed 38920618
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study
- ClinicalTrials.gov ID
- NCT04068038
- Acronym / sponsor ID
- PARDS Asia / 2017/3076(2)
- Conditions
- Acute Respiratory Distress Syndrome, Pediatric Intensive Care Unit, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- 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, Post Graduate Institute of Medical Education and Research, Chandigarh, Rumah Sakit Anak dan Bunda Harapan Kita, RSUP Prof. Dr. I.G.N.G. Ngoerahal, General Hospital of North Sumatera University, Hyogo Prefectural Kobe Children's Hospital, Aga Khan University, National University Hospital, Singapore, Singapore Clinical Research Institute
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS
Key exclusion criteria (2 listed)
- Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
- High flow nasal cannula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation protocolAn evidence based ventilation protocol will be implemented at participating sites. This will include limits on peak inspiratory pressure (28cmH2O), driving pressure (16cmH2O), tidal volume (mild 8ml/kg, mod/severe 6ml/kg), positive end expiratory pressure to fraction of inspired oxygen table, permissive hypercarbia (mild allow pH 7.30, mod/severe allow pH 7.20) and permissive hypoxia (mild SpO2 92-97%, mod/severe SpO2 88-92%). | Other | – |
Primary outcome
Prevalence of PARDS
Time frame: Through study completion
Number of participants diagnosed with PARDS over number of intensive care admissions
Mortality
Time frame: up to 60 days
Number of PARDS participants who died over number of participants diagnosed with PARDS
3 secondary outcomes
Ventilator free days
Time frame: up to 28 days
Intensive Care Unit free days
Time frame: up to 28 days
Extracorporeal membrane oxygenation
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 38920618Wong JJM, Dang H, Gan CS, Phan PH, Kurosawa H, Aoki K, Lee SW, Ong JSM, Fan LJ, Tai CW, Chuah SL, Lee PC, Chor YK, Ngu L, Anantasit N, Liu C, Xu W, Wati DK, Gede SIB, Jayashree M, Liauw F, Pon KM, Huang L, Chong JY, Zhu X, Hon KLE, Leung KKY, Samransamruajkit R, Cheung YB, Lee JH; Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN). Lung-Protective Ventilation for Pediatric Acute Respiratory Distress Syndrome: A Nonrandomized Controlled Trial. Crit Care Med. 2024 Oct 1;52(10):1602-1611. doi: 10.1097/CCM.0000000000006357. Epub 2024 Jun 26.
- Individual participant dataSharing planned: Undecided. IPD sharing will depend on ethics approval of individual sites
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Ju Ming Wong principal investigator
KK Women's and Children's Hospital
19 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Pediatric Intensive Care Unit, run by KK Women's and Children's Hospital at 19 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China, Malaysia, Thailand, Indonesia, Singapore and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PARDS (time frame: Through study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.