Clinical trial NCT04068038: Pediatric Acute Respiratory Distress Syndrome Asia Study
Official title: Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Pediatric Intensive Care Unit
Mechanical Ventilation
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Children's Hospital of Chongqing Medical University
name: Guangzhou Women and Children's Medical Center
name: Shengjing Hospital
name: Children's Hospital of Fudan University
name: Hong Kong Children's Hospital
name: Sarawak General Hospital
name: Universiti Kebangsaan Malaysia Medical Centre
name: University of Malaya
name: King Chulalongkorn Memorial Hospital
name: Siriraj Hospital
name: Ramathibodi Hospital
name: National Children's Hospital, Vietnam
name: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Rumah Sakit Anak dan Bunda Harapan Kita
name: Sanglah General Hospital
name: General Hospital of North Sumatera University
name: Hyogo Prefectural Kobe Children's Hospital
name: Aga Khan University
name: National University Hospital, Singapore
name: Singapore Clinical Research Institute
First posted: 2019-08-28
Enrollment: 738
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of PARDS
timeFrame: Through study completion
measure: Mortality
timeFrame: up to 60 days
Secondary outcomes:
measure: Ventilator free days
timeFrame: up to 28 days
measure: Intensive Care Unit free days
timeFrame: up to 28 days
measure: Extracorporeal membrane oxygenation
timeFrame: up to 28 days
Other outcomes:
measure: Composite mortality and ECMO
timeFrame: up to 60 days
measure: Sensitivity analysis
timeFrame: up to 60 days
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangzhou
city: Shenyang
country: China
facility: Shengjing hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Chongqing
country: China
facility: Chongqing Hospital
state: Sichuan
city: Kowloon Bay
country: Hong Kong
facility: Hong Kong Children's Hospital
state: Kowloon
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Denpasar
country: Indonesia
facility: Sanglah Hospital Denpasar
state: Bali
city: Jakarta
country: Indonesia
facility: Harapan Kita Children and Women hospital
city: Hyōgo
country: Japan
facility: Hyogo Prefectural Kobe Children's Hospital
state: Kobe
city: Bandar Tun Razak
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi hospital
city: Dong Da
country: Vietnam
facility: National Hospital of Pediatrics
state: Hanoi
Study officials:
affiliation: KK Women's and Children's Hospital
name: Judith Ju Ming Wong
role: PRINCIPAL_INVESTIGATOR
References: