Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-04 @ 4:14 AM
Study NCT ID:
NCT04113434
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2019-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 Day Mortality in Pediatric ARDS.', 'timeFrame': '28 days', 'description': '28 day all cause mortality.'}, {'measure': 'Presence of two or more endotypes in Pediatric ARDS.', 'timeFrame': 'Within 24 hours of ARDS onset', 'description': 'Stratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.'}, {'measure': 'Occurrence of de novo sub-phenotypes in pediatric ARDS using biomarkers and whole genome transcriptomics of peripheral blood.', 'timeFrame': 'Within 24 hours of ARDS onset.', 'description': 'Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.'}], 'secondaryOutcomes': [{'measure': 'ventilator-free days at 28 days.', 'timeFrame': '28 days', 'description': 'composite endpoint of days alive and free of mechanical ventilation by day 28.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress Syndrome', 'ARDS'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '38591949', 'type': 'DERIVED', 'citation': 'Whitney JE, Johnson GM, Varisco BM, Raby BA, Yehya N. Biomarker-Based Risk Stratification Tool in Pediatric Acute Respiratory Distress Syndrome: Single-Center, Longitudinal Validation in a 2014-2019 Cohort. Pediatr Crit Care Med. 2024 Jul 1;25(7):599-608. doi: 10.1097/PCC.0000000000003512. Epub 2024 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of the study is to risk stratify pediatric Acute Respiratory Distress Syndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order to appropriately target therapies in future trials. This is a prospective, multicenter study of 500 intubated children with ARDS, with planned blood collection within 24 hours of ARDS onset and subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.', 'detailedDescription': 'Investigators will measure pre-determined biomarkers with known or suspected association with ARDS severity or outcome. Simultaneously, investigators will measure gene expression of peripheral blood. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latent class analysis, and hierarchical clustering with the goal of identifying sub-phenotypes of ARDS. These sub-phenotypes will be examined for association with outcome (primary is 28-day mortality), and explicitly tested for variation in response to exogenous treatments (e.g., corticosteroids).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '44 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants to adolescents between the ages of 44 weeks and 17.5 years, who are admitted to PICU for acute respiratory failure requiring invasive mechanical ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation\n2. age \\> 44 weeks corrected gestational age and \\< 17.5 years\n3. invasive mechanical ventilation via endotracheal tube\n4. bilateral infiltrates on chest radiograph\n5. oxygenation index (OI) ≥ 4; or oxygen saturation index (OSI) ≥ 5 on 2 consecutive measurements at least 4 hours apart but \\< 24 hours apart\n6. invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation criteria\n\nExclusion Criteria:\n\n1. weight \\< 3 kilograms\n2. cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA))\n3. tracheostomy at time of screening\n4. invasively ventilated for \\> 7 days when meet ARDS criteria above\n5. cardiac failure as predominant cause of respiratory failure\n6. primary obstructive airway disease (asthma, bronchiolitis) by judgement of clinician as the primary cause of respiratory failure\n7. alternative known chronic lung disease as cause of respiratory failure (cystic fibrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis, cryptogenic organizing pneumonia)\n8. severe neurologic morbidity not expected to survive \\> 72 hours\n9. any limitations of care at time of screening\n10. previous enrollment in this study'}, 'identificationModule': {'nctId': 'NCT04113434', 'acronym': 'LEOPARDS', 'briefTitle': 'Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '19-016271'}, 'secondaryIdInfos': [{'id': 'R01HL148054', 'link': 'https://reporter.nih.gov/quickSearch/R01HL148054', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Variety Children's Hospital D/B/A Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Emory", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's at Indiana University Health", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooperman Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn State Hershey Children's Hospital", 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital / Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Nadir Yehya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Gene expression data will be released to Gene Expression Omnibus simultaneously with the publication of the data. Biomarker data will be released within 2 years of publication of the main manuscript.', 'ipdSharing': 'YES', 'description': 'Specific consent will be obtained to store blood and use data for future research. We will share data with the research community using the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) program at NHLBI, and we will follow suggested guidelines for de-identifying the data (coding of site IDs, conversion of dates to study days).\n\nPursuant to the NIH policy, all data obtained from this proposal will be made available for research by qualified individuals within the scientific community after publication of the proposed studies. Gene expression data from Aims 2 and 3 will be made available simultaneous with publication of the results of these aims by uploading to the Gene Expression Omnibus. For dissemination of plasma biomarker results and the associated clinical dataset, we will use BioLINCC program at NHLBI, with release of a de-identified dataset with untraceable identifiers within 2 years of publication of the main manuscript.', 'accessCriteria': "We will follow NHLBI's guidelines for accessing BioLINCC data."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': "Akron Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital and Health System Foundation, Wisconsin", 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, {'name': "Nicklaus Children's Hospital", 'class': 'UNKNOWN'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'Cooperman Barnabas Medical Center', 'class': 'UNKNOWN'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, {'name': "Children's Hospital Colorado", 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}