Actively Recruiting

Age: 14Days - 20Years
All Genders
NCT05388708

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

Led by University of Michigan · Updated on 2025-12-24

550

Participants Needed

99

Research Sites

347 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. The 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Days - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Time between intubation and ECMO cannulation is less than 240 hours (10 days)
  • ECMO support type is respiratory (VV or VA cannulation)
  • Chest radiograph with bilateral lung disease
  • Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation
  • Oxygenation index (OI) criteria: One OI 63 16 or Two OIs 63 12 and 64 16 at least four hours apart
  • Oxygen saturation index (OSI) criteria: Two OSIs 63 10 at least four hours apart or One OI 63 12 and 64 16 and One OSI 63 10 at least four hours apart
Not Eligible

You will not qualify if you...

  • Previously enrolled in PROSpect
  • Perinatal related lung disease
  • Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
  • Respiratory failure caused by cardiac failure or fluid overload
  • Cyanotic congenital heart disease
  • Cardiomyopathy
  • Primary pulmonary hypertension (PAH)
  • Unilateral lung disease
  • Intubated for status asthmaticus
  • Obstructive airway disease
  • Bronchiolitis obliterans
  • Post hematopoietic stem cell transplant
  • Post lung transplant
  • Home ventilator dependent
  • Neuromuscular respiratory failure
  • Head trauma managed with hyperventilation
  • Intracranial bleeding
  • Unstable spine, femur or pelvic fractures
  • Acute abdominal process or open abdomen
  • Family or medical team decided not to provide full support
  • Enrolled in interventional clinical trial not approved for co-enrollment except cancer protocols
  • Known pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 99 locations

1

Children's of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

3

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

4

Loma Linda University Children's Hospital

Loma Linda, California, United States, 92354

Actively Recruiting

5

UCLA Mattel Children's Hospital

Los Angeles, California, United States, 90095

Actively Recruiting

6

Valley Children's Hospital

Madera, California, United States, 93636

Actively Recruiting

7

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

Actively Recruiting

8

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

9

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

Actively Recruiting

10

UCSF Benioff Children's Hospital - San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

11

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

12

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

13

Yale New Haven Children's Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

14

Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States, 19803

Actively Recruiting

15

UF Health Shands Children's Hospital

Gainesville, Florida, United States, 32608

Actively Recruiting

16

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Withdrawn

17

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, United States, 32806

Actively Recruiting

18

Nemours Children's Hospital, Florida

Orlando, Florida, United States, 32827

Actively Recruiting

19

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

Actively Recruiting

20

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, United States, 96826

Actively Recruiting

21

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

Chicago, Illinois, United States, 60611

Actively Recruiting

22

Comer Children's Hospital

Chicago, Illinois, United States, 60637

Actively Recruiting

23

OSF Healthcare Children's Hospital of Illinois

Peoria, Illinois, United States, 61637

Actively Recruiting

24

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

25

University of Iowa Health Care Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

Actively Recruiting

26

Norton Children's Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

27

Ochsner LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Actively Recruiting

28

University of Maryland Children's Hospital

Baltimore, Maryland, United States, 21201

Withdrawn

29

Johns Hopkins Children's Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

30

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

31

University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

32

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

33

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

34

Children's Minnesota Hospital

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

35

M Health Fairview Masonic Children's Hospital

Minneapolis, Minnesota, United States, 55454

Withdrawn

36

Mayo Eugenio Litta Children's Hospital

Rochester, Minnesota, United States, 55902

Actively Recruiting

37

Children's Mercy

Kansas City, Missouri, United States, 64108

Actively Recruiting

38

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States, 63104

Actively Recruiting

39

St. Louis Children's Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

40

Children's Nebraska

Omaha, Nebraska, United States, 68114

Actively Recruiting

41

UNM Children's Hospital

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

42

John R. Oishei Children's Hospital

Buffalo, New York, United States, 14203

Actively Recruiting

43

Hassenfeld Children's Hospital at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

44

NewYork-Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States, 10032

Actively Recruiting

45

NewYork-Presbyterian Komansky Children's Hospital

New York, New York, United States, 10065

Actively Recruiting

46

Cohen Children's Medical Center

Queens, New York, United States, 11040

Actively Recruiting

47

N.C. Children's Hospital

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

48

Duke Children's Hospital & Health Center

Durham, North Carolina, United States, 27705

Actively Recruiting

49

Atrium Health Wake Forest Baptist | Brenner Children's Hospital

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

50

Akron Children's Hospital

Akron, Ohio, United States, 44308

Actively Recruiting

51

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

52

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

53

Nationwide Children's Hospital

Columbus, Ohio, United States, 43215

Actively Recruiting

54

Oklahoma Children's Hospital OU Health

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

55

OHSU Doernbecher Children's Hospital

Portland, Oregon, United States, 97239

Actively Recruiting

56

Penn State Health Children's Hospital

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

57

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

58

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

59

Hasbro Children's

Providence, Rhode Island, United States, 02903

Actively Recruiting

60

MUSC Shawn Jenkins Children's Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

61

Sanford Children's Hospital

Sious Falls, South Dakota, United States, 57105

Actively Recruiting

62

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

63

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

64

Dell Children's Medical Center

Austin, Texas, United States, 78723

Actively Recruiting

65

Medical City Children's Hospital

Dallas, Texas, United States, 75230

Actively Recruiting

66

Children's Medical Center Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

67

Children's Memorial Hermann Hospital

Houston, Texas, United States, 77030

Actively Recruiting

68

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

69

University Health Women's & Children's Hospital

San Antonio, Texas, United States, 78229

Actively Recruiting

70

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Actively Recruiting

71

UVA Children's Hospital

Charlottesville, Virginia, United States, 22903

Actively Recruiting

72

Inova L.J. Murphy Children's Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

73

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States, 23219

Withdrawn

74

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

75

UW Health American Family Children's Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

76

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

77

The Royal Children's Hospital Melbourne

Melbourne, Australia, VIC 3052

Actively Recruiting

78

Perth Children's Hospital

Perth, Australia, WA 6009

Actively Recruiting

79

Queensland Children's Hospital

South Brisbane, Australia, QLD 4101

Actively Recruiting

80

The Children's Hospital at Westmead

Westmead, Australia, NSW 2145,

Actively Recruiting

81

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

82

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Actively Recruiting

83

Pontificia Universidad

Santiago, Chile, 8331150

Actively Recruiting

84

Fundacion Cardiovascular De Colombia

Floridablanca, Colombia, 681004

Actively Recruiting

85

Istituto Giannina Gaslini

Genoa, Italy, 16147

Actively Recruiting

86

Starship Children's Hospital

Grafton, Aukland, New Zealand, 1023

Actively Recruiting

87

Hospital de Santa Maria

Lisbon, Portugal, 1649-028

Actively Recruiting

88

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

Barcelona, Spain, 08035

Actively Recruiting

89

Sant Joan de Deu Barcelona Hospital

Barcelona, Spain, 08950

Actively Recruiting

90

Hospital Gregorio Maranon

Madrid, Spain, 28007

Actively Recruiting

91

ECMO Centrum Karolinska

Stockholm, Sweden, 17176

Actively Recruiting

92

Royal Hospital for Children

Glasgow, United Kingdom, G51 4FT

Actively Recruiting

93

Leicester Children's Hospital

Leicester, United Kingdom, LE3 9QP

Actively Recruiting

94

Alder Hey Children's Hospital

Liverpool, United Kingdom, L12 2AP

Actively Recruiting

95

Evelina London Children's Hospital

London, United Kingdom, SE1 7EH

Actively Recruiting

96

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Actively Recruiting

97

Great Ormond Street Hospital for Children

London, United Kingdom, WC1N 3JH

Actively Recruiting

98

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE77DN

Actively Recruiting

99

Southampton Children's Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

K

Kelli McDonough, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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