[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469123":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":1535,"collaborators":1538,"id":1542,"slug":1543,"hasResults":1544,"nctId":1545,"briefTitle":1546,"officialTitle":1546,"acronym":1547,"eligibilityCriteria":1548,"healthyVolunteers":1544,"sex":1549,"minAge":1550,"maxAge":1551,"enrollmentInfo":1552,"targetDuration":10,"studyType":1555,"phases":10,"briefSummary":1556,"conditions":1557,"keywords":1560,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":1568,"lastUpdatePostDateStruct":1569,"startDateStruct":1572,"completionDateStruct":1574,"leadSponsor":1576,"locationsCount":1577},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care ECMO Cohort",null,"The cohort will be comprised of 550 patients, aged 14 days to 20 years, who go on extracorporeal membrane oxygenation (ECMO) support due to pediatric acute respiratory distress syndrome (PARDS) at physician discretion. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \\\u003C 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \\\u003C 16 and one OSI \\> 10 (at least 4 hours apart) Subjects must be on mechanical ventilation for less than 240 hours (10 days) prior to cannulation. These measures must be after endotracheal intubation and before ECMO start. Chest radiograph prior to ECMO must show bilateral lung disease.\n\nSubjects cannulated on ECMO for no more than 96 hours prior to gaining consent.",[13],"Device: ECMO support",{"label":15,"type":10,"description":16,"interventionNames":17},"PROSpect protocolized therapies cohort","The cohort will be comprised of 1000 patients, aged 14 days to 20 years, who are endotracheally intubated for PARDS. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \\\u003C 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \\\u003C 16 and one OSI \\> 10 (at least 4 hours apart). These measures must be after endotracheal intubation. Chest radiograph must show bilateral lung disease. Patient must be enrolled in a clinical trial Prone and Oscillation Pediatric Clinical Trial (PROSpect) NCT01515787 which is distinct from ASCEND.\n\nPROSpect is a response adaptive randomized clinical trial, testing the impact of supine\u002Fprone positioning and conventional mechanical ventilation\u002Fhigh-frequency oscillatory ventilation on short and long-term clinical outcomes in children with severe PARDS. PROSpect manages severe PARDS subjects using a rigorous protocol that reserves ECMO for protocol failure.",[18],"Other: PROSpect protocolized therapies",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","ECMO support","ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"PROSpect protocolized therapies","PROSpect is testing the impact of supine\u002Fprone positioning and conventional mechanical ventilation (CMV)\u002Fhigh-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure.\n\nThe CMV group targets an exhaled tidal volume of 5-7mL\u002Fkg of ideal body weight and a peak inspiratory pressure \\\u003C28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \\\u003C 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.",[15],[30],{"name":31,"affiliation":5,"role":32},"Ryan Barbaro, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Kelli McDonough, MS","CONTACT","734-232-1998","kellimcd@umich.edu",[40,60,76,92,108,123,138,153,168,183,198,214,230,245,261,277,287,302,314,330,346,362,374,389,406,422,438,455,465,477,494,507,522,537,553,559,574,590,605,617,633,649,665,679,691,703,718,734,749,764,780,795,810,825,841,857,873,888,903,919,936,947,963,978,994,1009,1021,1036,1047,1062,1078,1094,1109,1118,1134,1150,1165,1183,1199,1215,1231,1250,1267,1286,1304,1321,1339,1356,1373,1385,1403,1420,1437,1452,1467,1482,1494,1506,1521],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Children's of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.80249,33.52066,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":10,"email":58},"Robert Richter, MD","(205) 638-9100","rrichter@peds.aub.edu",{"name":56,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Phoenix Children's Hospital","Phoenix","Arizona","85016",{"type":49,"coordinates":66},[67,68],-112.07404,33.44838,{"lat":68,"lon":67},[71,75],{"name":72,"role":36,"phone":73,"phoneExt":10,"email":74},"Erin Kreml, MD","(602) 933-1000","ekreml@phoenixchildrens.com",{"name":72,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":77,"status":42,"city":78,"state":79,"zip":80,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":49,"coordinates":82},[83,84],-92.28959,34.74648,{"lat":84,"lon":83},[87,91],{"name":88,"role":36,"phone":89,"phoneExt":10,"email":90},"Matthew Malone, MD","(501) 441-3453","MPMalone@uams.edu",{"name":88,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":93,"status":42,"city":94,"state":95,"zip":96,"country":46,"countryCode":47,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Loma Linda University Children's Hospital","Loma Linda","California","92354",{"type":49,"coordinates":98},[99,100],-117.26115,34.04835,{"lat":100,"lon":99},[103,107],{"name":104,"role":36,"phone":105,"phoneExt":10,"email":106},"Merrick Lopez, MD","(909) 558-8000","MLopez@llu.edu",{"name":104,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":109,"status":42,"city":110,"state":95,"zip":111,"country":46,"countryCode":47,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"UCLA Mattel Children's Hospital","Los Angeles","90095",{"type":49,"coordinates":113},[114,115],-118.24368,34.05223,{"lat":115,"lon":114},[118,122],{"name":119,"role":36,"phone":120,"phoneExt":10,"email":121},"Neeraj Srivastava, MD","(310) 825-9111","neerajsrivastava@mednet.ucla.edu",{"name":119,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":124,"status":42,"city":125,"state":95,"zip":126,"country":46,"countryCode":47,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Valley Children's Hospital","Madera","93636",{"type":49,"coordinates":128},[129,130],-120.06072,36.96134,{"lat":130,"lon":129},[133,137],{"name":134,"role":36,"phone":135,"phoneExt":10,"email":136},"Harry Kallas, MD","(559) 353-3000","HKallas@valleychildrens.org",{"name":134,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":139,"status":42,"city":140,"state":95,"zip":141,"country":46,"countryCode":47,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"UCSF Benioff Children's Hospital Oakland","Oakland","94609",{"type":49,"coordinates":143},[144,145],-122.2708,37.80437,{"lat":145,"lon":144},[148,152],{"name":149,"role":36,"phone":150,"phoneExt":10,"email":151},"Mandeep Chadha, MD","(510) 428-3000","Mandeep.Chadha@ucsf.edu",{"name":149,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":154,"status":42,"city":155,"state":95,"zip":156,"country":46,"countryCode":47,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Children's Hospital of Orange County","Orange","92868",{"type":49,"coordinates":158},[159,160],-117.85311,33.78779,{"lat":160,"lon":159},[163,167],{"name":164,"role":36,"phone":165,"phoneExt":10,"email":166},"Adam Schwarz, MD","(714) 997-3000","ASchwarz@choc.org",{"name":164,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":169,"status":42,"city":170,"state":95,"zip":171,"country":46,"countryCode":47,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Lucile Packard Children's Hospital Stanford","Palo Alto","94304",{"type":49,"coordinates":173},[174,175],-122.14302,37.44188,{"lat":175,"lon":174},[178,182],{"name":179,"role":36,"phone":180,"phoneExt":10,"email":181},"Timothy Cornell, MD","(650) 497-8000","tcornell@stanford.edu",{"name":179,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":184,"status":42,"city":185,"state":95,"zip":186,"country":46,"countryCode":47,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"UCSF Benioff Children's Hospital - San Francisco","San Francisco","94158",{"type":49,"coordinates":188},[189,190],-122.41942,37.77493,{"lat":190,"lon":189},[193,197],{"name":194,"role":36,"phone":195,"phoneExt":10,"email":196},"Shan Ward, MD","(415) 476-1000","shan.ward@ucsf.edu",{"name":194,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":199,"status":42,"city":200,"state":201,"zip":202,"country":46,"countryCode":47,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":49,"coordinates":204},[205,206],-104.83192,39.72943,{"lat":206,"lon":205},[209,213],{"name":210,"role":36,"phone":211,"phoneExt":10,"email":212},"John Kim, MD","720-777-1234","John.Kim@childrenscolorado.org",{"name":210,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":215,"status":42,"city":216,"state":217,"zip":218,"country":46,"countryCode":47,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Connecticut Children's Medical Center","Hartford","Connecticut","06106",{"type":49,"coordinates":220},[221,222],-72.68509,41.76371,{"lat":222,"lon":221},[225,229],{"name":226,"role":36,"phone":227,"phoneExt":10,"email":228},"Allison Cowl, MD","(860) 545-9000","acowl@connecticutchildrens.org",{"name":226,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":231,"status":42,"city":232,"state":217,"zip":233,"country":46,"countryCode":47,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Yale New Haven Children's Hospital","New 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Hospital","Gainesville","Florida","32608",{"type":49,"coordinates":267},[268,269],-82.32483,29.65163,{"lat":269,"lon":268},[272,276],{"name":273,"role":36,"phone":274,"phoneExt":10,"email":275},"Kourtney Guthrie, MD","(352) 733-0111","ksnodgrass@ufl.edu",{"name":273,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":278,"status":279,"city":280,"state":264,"zip":281,"country":46,"countryCode":47,"cosmosGeoPoint":282,"geoPoint":286,"contacts":10},"Nicklaus Children's Hospital","WITHDRAWN","Miami","33155",{"type":49,"coordinates":283},[284,285],-80.19366,25.77427,{"lat":285,"lon":284},{"facility":288,"status":42,"city":289,"state":264,"zip":290,"country":46,"countryCode":47,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Orlando Health Arnold Palmer Hospital for Children","Orlando","32806",{"type":49,"coordinates":292},[293,294],-81.37924,28.53834,{"lat":294,"lon":293},[297,301],{"name":298,"role":36,"phone":299,"phoneExt":10,"email":300},"Nicole Slone, MD","(407) 649-9111","Nicole.Slone@orlandohealth.com",{"name":298,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":303,"status":42,"city":289,"state":264,"zip":304,"country":46,"countryCode":47,"cosmosGeoPoint":305,"geoPoint":307,"contacts":308},"Nemours Children's Hospital, Florida","32827",{"type":49,"coordinates":306},[293,294],{"lat":294,"lon":293},[309,313],{"name":310,"role":36,"phone":311,"phoneExt":10,"email":312},"Timothy Maul, MD","(407) 567-4000","timothy.maul@nemours.org",{"name":310,"role":32,"phone":10,"phoneExt":10,"email":10},{"facility":315,"status":42,"city":316,"state":317,"zip":318,"country":46,"countryCode":47,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Children's Healthcare of Atlanta","Atlanta","Georgia","30342",{"type":49,"coordinates":320},[321,322],-84.38798,33.749,{"lat":322,"lon":321},[325,329],{"name":326,"role":36,"phone":327,"phoneExt":10,"email":328},"Heather Viamonte, MD","(404) 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ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation:\n\nOne OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart\n\nExclusion Criteria:\n\n* Previously enrolled in PROSpect\n* Perinatal related lung disease\n* Congenital diaphragmatic hernia or congenital\u002Facquired diaphragm paralysis\n* Respiratory failure caused by cardiac failure or fluid overload\n* Cyanotic congenital heart disease\n* Cardiomyopathy\n* Primary pulmonary hypertension (PAH)\n* Unilateral lung disease\n* Intubated for status asthmaticus\n* Obstructive airway disease\n* Bronchiolitis obliterans\n* Post hematopoietic stem cell transplant\n* Post lung transplant\n* Home ventilator dependent\n* Neuromuscular respiratory failure\n* Head trauma: (managed with hyperventilation)\n* Intracranial bleeding\n* Unstable spine, femur or pelvic fractures\n* Acute abdominal process\u002Fopen abdomen\n* Family\u002Fmedical team have decided to not provide full support\n* Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.\n* Known pregnancy","ALL","14 Days","20 Years",{"count":1553,"type":1554},550,"ESTIMATED","OBSERVATIONAL","ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives.\n\nThe first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.",[1558,1559],"Acute Respiratory Distress Syndrome","Extracorporeal Membrane Oxygenation",[1561,1558,1559,1562,1563,1564,1565,1566,1567],"ARDS","ECMO","Extracorporeal Life Support","ECLS","Pediatric","Quality of Life","Functional Status","2025-12-22",{"date":1570,"type":1571},"2025-12-24","ACTUAL",{"date":1573,"type":1571},"2021-02-04",{"date":1575,"type":1554},"2027-09-30",{"name":5,"class":6},99]