Pediatric Acute Respiratory Distress Syndrome Asia Study

Acute Respiratory Distress Syndrome Clinical Trial

— PARDS Asia  

Official title:

Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04068038
• Other study ID #: 2017/3076(2)
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 738
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Mechanical Ventilation
• Pediatric Intensive Care Unit
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• 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%).

Locations

Country	Name	City	State
China	Chongqing Hospital	Chongqing	Sichuan
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangzhou
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Shengjing hospital of China Medical University	Shenyang	Liaoning
Hong Kong	Hong Kong Children's Hospital	Kowloon Bay	Kowloon
India	Post Graduate Institute of Medical Education and Research	Chandigarh
Indonesia	Sanglah Hospital Denpasar	Denpasar	Bali
Indonesia	Harapan Kita Children and Women hospital	Jakarta
Japan	Hyogo Prefectural Kobe Children's Hospital	Hyogo	Kobe
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Bandar Tun Razak	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Pakistan	Aga Khan University Hospital	Karachi
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital, Singapore	Singapore
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Ramathibodi hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok
Vietnam	National Hospital of Pediatrics	Dong Da	Hanoi

Sponsors (21)

Lead Sponsor

Collaborator

KK Women's and Children's Hospital

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

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Indonesia,  Japan,  Malaysia,  Pakistan,  Singapore,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite mortality and ECMO	Number of PARDS participants who died or required ECMO over total number of participants diagnosed with PARDS	up to 60 days
Other	Sensitivity analysis	Mortality and secondary outcomes excluding limitation of care orders	up to 60 days
Primary	Prevalence of PARDS	Number of participants diagnosed with PARDS over number of intensive care admissions	Through study completion
Primary	Mortality	Number of PARDS participants who died over number of participants diagnosed with PARDS	up to 60 days
Secondary	Ventilator free days	Number of days alive and free of mechanical ventilation	up to 28 days
Secondary	Intensive Care Unit free days	Number of days alive and discharge from the intensive care unit	up to 28 days
Secondary	Extracorporeal membrane oxygenation	Number of participants who require ECMO	up to 28 days