Pediatric Acute Respiratory Distress Syndrome Asia Study

NCT ID: NCT04068038

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

738 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome Pediatric Intensive Care Unit Mechanical Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ventilation protocol

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%).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Hong Kong Children's Hospital

OTHER

Sponsor Role collaborator

Sarawak General Hospital

OTHER

Sponsor Role collaborator

Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role collaborator

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role collaborator

Ramathibodi Hospital

OTHER

Sponsor Role collaborator

National Children's Hospital, Vietnam

OTHER

Sponsor Role collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role collaborator

Rumah Sakit Anak dan Bunda Harapan Kita

UNKNOWN

Sponsor Role collaborator

Sanglah General Hospital

OTHER

Sponsor Role collaborator

General Hospital of North Sumatera University

UNKNOWN

Sponsor Role collaborator

Hyogo Prefectural Kobe Children's Hospital

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Singapore Clinical Research Institute

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Judith Wong Ju-Ming

Consultant Pediatric Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith Ju Ming Wong

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangzhou Women and Children's Medical Center

Guangzhou, Guangzhou, China

Site Status

Shengjing hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Chongqing Hospital

Chongqing, Sichuan, China

Site Status

Hong Kong Children's Hospital

Kowloon Bay, Kowloon, Hong Kong

Site Status

Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status

Sanglah Hospital Denpasar

Denpasar, Bali, Indonesia

Site Status

Harapan Kita Children and Women hospital

Jakarta, , Indonesia

Site Status

Hyogo Prefectural Kobe Children's Hospital

Hyōgo, Kobe, Japan

Site Status

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia

Site Status

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Aga Khan University Hospital

Karachi, , Pakistan

Site Status

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

National University Hospital, Singapore

Singapore, , Singapore

Site Status

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Ramathibodi hospital

Bangkok, , Thailand

Site Status

National Hospital of Pediatrics

Đống Đa, Hanoi, Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China Hong Kong India Indonesia Japan Malaysia Pakistan Singapore Thailand Vietnam

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38920618 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/3076(2)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.