protocolSection identificationModule nctId: NCT06369584, orgStudyIdInfo id: PEPAD, briefTitle: Prone Position During ECMO in Pediatric Patients With Severe ARDS, acronym: PEPAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Seventh Medical Center of PLA General Hospital, class: OTHER, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Xian Children's Hospital, collaborators name: Henan Provincial People's Hospital, collaborators name: People's Hospital of Guangxi, collaborators name: Guangdong Provincial People's Hospital, descriptionModule briefSummary: In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury., conditionsModule conditions: Pediatric Acute Respiratory Distress Syndrome, conditions: Extracorporeal Membrane Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: prone position, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Failure of supine position, secondaryOutcomes measure: ECMO successful weaning rate, secondaryOutcomes measure: Total duration of ECMO Support, secondaryOutcomes measure: Number of ECMO-free days, secondaryOutcomes measure: Duration of mechanical ventilation days after ECMO successful weaning., secondaryOutcomes measure: Duration of Pediatric Intensive Care Unit (PICU) stay., secondaryOutcomes measure: Duration of hospitalization, secondaryOutcomes measure: Incidence of brain injury before discharge, secondaryOutcomes measure: Number of days with organ failure, secondaryOutcomes measure: Number of days alive without organ failure, secondaryOutcomes measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes, secondaryOutcomes measure: Number of days with hemodynamic support with catecholamines, secondaryOutcomes measure: Number of days without hemodynamic support with catecholamines, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: seventh medical center of Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100700, country: China, contacts name: Xiaoyang Hong, M.D., role: CONTACT, phone: 13311057633, email: jyhongxy@163.com, contacts name: Zhe Zhao, role: CONTACT, phone: 18500179885, email: derekpicu@outlook.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Gansu Provincial Maternal and Child Health Care Hospital, city: Lanzhou, state: Gansu, zip: 730050, country: China, contacts name: Weikai Wang, M.D., role: CONTACT, phone: 0931-5188650, email: 35487284@qq.com, geoPoint lat: 36.05701, lon: 103.83987, locations facility: The Second School of Clinical Medicine, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Yuxiong Guo, M.D., role: CONTACT, phone: 13423661583, email: 2003kellylaw@163.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: The People's Hospital of Guangxi Zhuang Autonomous Region, city: Nanning, state: Guangxi, country: China, contacts name: Hanwu Huang, M.D., role: CONTACT, phone: 15107710327, email: 2503133021@qq.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan Children's Hospital, city: Zhengzhou, state: Henan, zip: 450014, country: China, contacts name: Feng Wang, M.D., role: CONTACT, phone: 0371-85515892, email: wang.f365@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Henan Provincial People's Hospital, city: Zhengzhou, state: Henan, zip: 463599, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xi'an Children's Hospital, city: Xi'an, state: Shaanxi, zip: 710002, country: China, contacts name: Yi Wang, M.D., role: CONTACT, phone: 18591953652, email: wangyichengxian@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False