Phase
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
Either supine or prone positioning and either CMV or HFOV
Clinical Study ID
Ages 2-20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Intubated and mechanically ventilated with high moderate-severe PARDS for <48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥12 or OSI ≥10). We require two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume). A second blood gas is not required for OI ≥16.
Exclusion
Exclusion criteria:
Perinatal related lung disease
Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragmparalysis
Respiratory failure explained by cardiac failure or fluid overload
Cyanotic heart disease
Cardiomyopathy
Unilateral lung disease
Primary pulmonary hypertension
Intubated for status asthmaticus
Obstructive airway disease (e.g., Severe airways disease without parenchymalinvolvement or disease characterized by hypercapnia with FiO2 <0.30 and/or evidenceof increased resistance visible on the flow - time scalar and/or presence ofintrinsic PEEP)
Active air leak
Bronchiolitis obliterans
Post hematopoietic stem cell transplant; specifically, patients receiving continuoussupplemental oxygen for three or more days prior to intubation; receivingnoninvasive ventilation for more than 24 hours prior to intubation; receiving morethan one vasoactive medication at time of meeting inclusion criteria; spending morethan four days in the PICU prior to intubation; supported on or with immediate plansfor renal replacement therapies; with two or more allogeneic transplants; whorelapsed after the transplant; or with diffuse alveolar hemorrhage
Post lung transplant
Home ventilator dependent with baseline Oxygen Saturation Index (OSI) >6
Neuromuscular respiratory failure
Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) oranatomical obstruction of the lower airway (e.g., mediastinal mass)
Facial surgery or trauma in previous 2 weeks
Head trauma (managed with hyperventilation)
Intracranial bleeding
Unstable spine, femur or pelvic fractures
Open abdomen
Currently receiving more than 6 consecutive hours of either prone positioning orHFOV
Supported on ECMO during the current admission
Family/medical team not providing full support (patient treatment considered futile)
Previously enrolled in current study
Enrolled in any other interventional clinical trial not approved for co-enrollment
Known pregnancy
Study Design
Study Description
Connect with a study center
Hospital de Pediatría J. P. Garrahan. SAMIC
Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1245AAM
ArgentinaSite Not Available
Hospital de Pediatría J. P. Garrahan. SAMIC
Buenos Aires, Caba C1245AAM
ArgentinaSite Not Available
Queensland Children's Hospital
South Brisbane, Queensland
AustraliaSite Not Available
Royal Children's Hospital
Melbourne, Victoria
AustraliaSite Not Available
Perth Children's Hospital
Perth, Western Australia 6840
AustraliaSite Not Available
Perth Children's Hospital
Perth 2063523, Western Australia 2058645 6840
AustraliaSite Not Available
Children's hospital at Westmead
Sydney,
AustraliaSite Not Available
Children's Hospital at Westmead
Sydney 2147714,
AustraliaSite Not Available
Sabara Hospital Infantil
São Paulo 3448439, Brazil
BrazilSite Not Available
Sabara Hospital Infantil
Sao Paulo,
BrazilSite Not Available
Hospital SEPACO
São Paulo,
BrazilSite Not Available
Hospital SEPACO
São Paulo 3448439,
BrazilSite Not Available
Alberta Children's Hospital
Calgary, Alberta T3B6A8
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte Justine
Montréal, Quebec H3T1C5
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte Justine
Montreal 6077243, Quebec 6115047 H3T1C5
CanadaSite Not Available
Guangzhou Women & Children's Hospital (Newtown)
Guangzhou,
ChinaSite Not Available
Guangzhou Women & Children's Hospital (Yuexiu)
Guangzhou,
ChinaSite Not Available
Münster University Hospital
Münster,
GermanySite Not Available
Münster University Hospital
Münster 2867543,
GermanySite Not Available
Rainbow Children's Hospital
Hyderabad,
IndiaSite Not Available
Rainbow Children's Hospital
Hyderabad 1269843,
IndiaSite Not Available
Hadassah Medical Center
Jerusalem,
IsraelSite Not Available
Hadassah Medical Center
Jerusalem 281184,
IsraelSite Not Available
Meyer Children's Hospital
Florence 3176959, Italy
ItalySite Not Available
Bambino Gesu Children's Hospital (Area Rossa Unit)
Rome 3169070, Italy
ItalySite Not Available
Policlinico S. Orsola-Malpighi University Hospital
Bologna,
ItalySite Not Available
Meyer Children's Hospital
Florence,
ItalySite Not Available
Instituto Giannina Gasilini
Genova,
ItalySite Not Available
Instituto Giannina Gasilini
Genova 8969657,
ItalySite Not Available
Bambino Gesu Children's Hospital
Rome,
ItalySite Not Available
Bambino Gesu Children's Hospital (Area Rossa Unit)
Rome,
ItalySite Not Available
Chonnam National University Hospital
Gwangju,
Korea, Republic ofSite Not Available
University of Malaysia Medical Center
Kuala Lumpur,
MalaysiaSite Not Available
University of Malaysia Medical Center
Kuala Lumpur 1735161,
MalaysiaSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
University Medical Center Groningen
Groningen 2755251,
NetherlandsSite Not Available
Starship Children's Hospital
Auckland,
New ZealandSite Not Available
Chonnam National University Hospital
Gwangju 1841811,
South KoreaSite Not Available
Cruces University Hospital
Barakaldo,
SpainSite Not Available
Faculty of Medicine Ramathibodi Hospital
Bangkok,
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
ThailandSite Not Available
King Chulalongkorn Memorial Hospital
Bangkok, 10330
ThailandSite Not Available
Faculty of Medicine Ramathibodi Hospital
Bangkok 1609350,
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok 1609350, 10700
ThailandSite Not Available
King Chulalongkorn Memorial Hospital
Bangkok 1609350, 10330
ThailandSite Not Available
Shaikh Khalifa Medical City
Abu Dhabi,
United Arab EmiratesSite Not Available
Shaikh Khalifa Medical City
Abu Dhabi 292968,
United Arab EmiratesSite Not Available
Birmingham Children's Hospital
Birmingham, UK
United KingdomSite Not Available
Birmingham Children's Hospital
Birmingham 2655603, UK
United KingdomSite Not Available
University Hospital Leicester NHS Trust
Leicester,
United KingdomSite Not Available
University Hospital Leicester NHS Trust
Leicester 2644668,
United KingdomSite Not Available
University Hospital Southampton NHS Foundation Trust
Southampton,
United KingdomSite Not Available
Children's of Alabama
Birmingham, Alabama 35233
United StatesSite Not Available
Children's of Alabama
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Banner Health
Phoenix, Arizona 85006
United StatesSite Not Available
Phoenix Children's Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Banner Health
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202
United StatesSite Not Available
Children's Hospital Orange County
Orange, California 92868
United StatesSite Not Available
Stanford Children's Health
Palo Alto, California 94304
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
UCSF Benioff Children's
San Francisco, California 94143
United StatesSite Not Available
Children's Hospital Orange County
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Stanford Children's Health
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesSite Not Available
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Nemours Foundation
Wilmington, Delaware 19803
United StatesSite Not Available
UF Shangs Children's Hospital
Gainesville, Florida 32610
United StatesSite Not Available
Holtz Children's Hospital
Miami, Florida 33136
United StatesSite Not Available
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96813
United StatesSite Not Available
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96813
United StatesSite Not Available
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Ann & Robert Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Riley Hospital for Children at IU Health
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children at IU Health
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
University of Iowa Stead Family Chlldren's Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Stead Family Chlldren's Hospital
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Norton Children's Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Bloomberg Children's Center, Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
University of Maryland Medical Center-Children's Hospital
Baltimore, Maryland 21201
United StatesSite Not Available
Bloomberg Children's Center, Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
CS Mott Children's Hospital
Ann Arbor, Michigan 48109
United StatesSite Not Available
CS Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Children's Hospital and Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Children's Hospital and Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesSite Not Available
University of New Mexico Children's Hospital
Albuquerque, New Mexico 87106
United StatesSite Not Available
The Children's Hospital of Montefiore
Bronx, New York 10467
United StatesSite Not Available
Cohen Children's Medical Center
Queens, New York 11040
United StatesSite Not Available
Cohen Children's Medical Center
Queens 5133273, New York 5128638 11040
United StatesSite Not Available
UNC Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Duke Children's Hospital
Durham, North Carolina 27710
United StatesSite Not Available
Duke Children's Hospital
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
UH Rainbow Babies & Children
Cleveland, Ohio 44106
United StatesSite Not Available
UH Rainbow Babies & Children
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Children's Hospital at Oklahoma University Medical Center
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Penn State Children's Hospital
Hershey, Pennsylvania 17033
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19014
United StatesSite Not Available
Penn State Children's Hospital
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19014
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
LeBonheur Children's Hospital
Memphis, Tennessee 38103
United StatesSite Not Available
LeBonheur Children's Hospital
Memphis 4641239, Tennessee 4662168 38103
United StatesSite Not Available
Children's Health Dallas
Dallas, Texas 75235
United StatesSite Not Available
Medical City Dallas
Dallas, Texas 75230
United StatesSite Not Available
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
Children's Hospital of San Antonio
San Antonio, Texas 78207
United StatesSite Not Available
Children's Health Dallas
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Medical City Dallas
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Texas Children's Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286 78207
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
Children's Hospital at Richmond at VCU
Richmond, Virginia 23219
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
American Family Children's Hospital, University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53201
United StatesSite Not Available
American Family Children's Hospital, University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53201
United StatesSite Not Available

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