ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

RecruitingOBSERVATIONAL
Enrollment

550

Participants

Timeline

Start Date

February 4, 2021

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Acute Respiratory Distress SyndromeExtracorporeal Membrane Oxygenation
Interventions
DEVICE

ECMO support

ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.

OTHER

PROSpect protocolized therapies

"PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-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.~The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 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 \< 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."

Trial Locations (99)

1023

RECRUITING

Starship Children's Hospital, Grafton

10016

RECRUITING

Hassenfeld Children's Hospital at NYU Langone, New York

10032

RECRUITING

NewYork-Presbyterian Morgan Stanley Children's Hospital, New York

10065

RECRUITING

NewYork-Presbyterian Komansky Children's Hospital, New York

11040

RECRUITING

Cohen Children's Medical Center, Queens

14203

RECRUITING

John R. Oishei Children's Hospital, Buffalo

15224

RECRUITING

UPMC Children's Hospital of Pittsburgh, Pittsburgh

16147

RECRUITING

Istituto Giannina Gaslini, Genoa

17033

RECRUITING

Penn State Health Children's Hospital, Hershey

17176

RECRUITING

ECMO Centrum Karolinska, Stockholm

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

Nemours Children's Hospital, Delaware, Wilmington

21201

WITHDRAWN

University of Maryland Children's Hospital, Baltimore

21287

RECRUITING

Johns Hopkins Children's Center, Baltimore

22042

RECRUITING

Inova L.J. Murphy Children's Hospital, Falls Church

22903

RECRUITING

UVA Children's Hospital, Charlottesville

23219

WITHDRAWN

Children's Hospital of Richmond at VCU, Richmond

27514

RECRUITING

N.C. Children's Hospital, Chapel Hill

27705

RECRUITING

Duke Children's Hospital & Health Center, Durham

28007

RECRUITING

Hospital Gregorio Maranon, Madrid

29425

RECRUITING

MUSC Shawn Jenkins Children's Hospital, Charleston

30342

RECRUITING

Children's Healthcare of Atlanta, Atlanta

32608

RECRUITING

UF Health Shands Children's Hospital, Gainesville

32806

RECRUITING

Orlando Health Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Florida, Orlando

33155

WITHDRAWN

Nicklaus Children's Hospital, Miami

35233

RECRUITING

Children's of Alabama, Birmingham

37232

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

38103

RECRUITING

Le Bonheur Children's Hospital, Memphis

40202

RECRUITING

Norton Children's Hospital, Louisville

43215

RECRUITING

Nationwide Children's Hospital, Columbus

44106

RECRUITING

Cleveland Clinic Children's Hospital, Cleveland

44308

RECRUITING

Akron Children's Hospital, Akron

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48109

RECRUITING

University of Michigan - Mott Children's Hospital, Ann Arbor

48201

RECRUITING

Children's Hospital of Michigan, Detroit

49503

RECRUITING

Helen DeVos Children's Hospital, Grand Rapids

52242

RECRUITING

University of Iowa Health Care Stead Family Children's Hospital, Iowa City

53226

RECRUITING

Children's Wisconsin, Milwaukee

53792

RECRUITING

UW Health American Family Children's Hospital, Madison

55404

RECRUITING

Children's Minnesota Hospital, Minneapolis

55454

WITHDRAWN

M Health Fairview Masonic Children's Hospital, Minneapolis

55902

RECRUITING

Mayo Eugenio Litta Children's Hospital, Rochester

57105

RECRUITING

Sanford Children's Hospital, Sious Falls

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

60637

RECRUITING

Comer Children's Hospital, Chicago

61637

RECRUITING

OSF Healthcare Children's Hospital of Illinois, Peoria

63104

RECRUITING

Cardinal Glennon Children's Hospital, St Louis

63110

RECRUITING

St. Louis Children's Hospital, St Louis

64108

RECRUITING

Children's Mercy, Kansas City

68114

RECRUITING

Children's Nebraska, Omaha

71103

RECRUITING

Ochsner LSU Health Shreveport, Shreveport

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

73104

RECRUITING

Oklahoma Children's Hospital OU Health, Oklahoma City

75230

RECRUITING

Medical City Children's Hospital, Dallas

75235

RECRUITING

Children's Medical Center Dallas, Dallas

77030

RECRUITING

Children's Memorial Hermann Hospital, Houston

RECRUITING

Texas Children's Hospital, Houston

78229

RECRUITING

University Health Women's & Children's Hospital, San Antonio

78723

RECRUITING

Dell Children's Medical Center, Austin

80045

RECRUITING

Children's Hospital Colorado, Aurora

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

87106

RECRUITING

UNM Children's Hospital, Albuquerque

90095

RECRUITING

UCLA Mattel Children's Hospital, Los Angeles

92354

RECRUITING

Loma Linda University Children's Hospital, Loma Linda

92868

RECRUITING

Children's Hospital of Orange County, Orange

93636

RECRUITING

Valley Children's Hospital, Madera

94158

RECRUITING

UCSF Benioff Children's Hospital - San Francisco, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital Stanford, Palo Alto

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

96826

RECRUITING

Kapi'olani Medical Center for Women & Children, Honolulu

97239

RECRUITING

OHSU Doernbecher Children's Hospital, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

681004

RECRUITING

Fundacion Cardiovascular De Colombia, Floridablanca

8331150

RECRUITING

Pontificia Universidad, Santiago

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

06511

RECRUITING

Yale New Haven Children's Hospital, New Haven

02115

RECRUITING

Boston Children's Hospital, Boston

North Carolina

RECRUITING

"Atrium Health Wake Forest Baptist , Brenner Children's Hospital"

02903

RECRUITING

Hasbro Children's, Providence

VIC 3052

RECRUITING

The Royal Children's Hospital Melbourne, Melbourne

WA 6009

RECRUITING

Perth Children's Hospital, Perth

QLD 4101

RECRUITING

Queensland Children's Hospital, South Brisbane

NSW 2145,

RECRUITING

The Children's Hospital at Westmead, Westmead

T6G 2B7

RECRUITING

Stollery Children's Hospital, Edmonton

M5G 1E8

RECRUITING

The Hospital for Sick Children, Toronto

1649-028

RECRUITING

Hospital de Santa Maria, Lisbon

08035

RECRUITING

Children's Hospital and Vall d' Hebron Women's Hospital, Barcelona

08950

RECRUITING

Sant Joan de Deu Barcelona Hospital, Barcelona

G51 4FT

RECRUITING

Royal Hospital for Children, Glasgow

LE3 9QP

RECRUITING

Leicester Children's Hospital, Leicester

L12 2AP

RECRUITING

Alder Hey Children's Hospital, Liverpool

SE1 7EH

RECRUITING

Evelina London Children's Hospital, London

SW3 6NP

RECRUITING

Royal Brompton Hospital, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital for Children, London

NE77DN

RECRUITING

Freeman Hospital, Newcastle upon Tyne

SO16 6YD

RECRUITING

Southampton Children's Hospital, Southampton

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Michigan

OTHER