Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 8:37 AM
Study NCT ID:
NCT01274260
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2011-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Steroids in Pediatric Acute Lung Injury/ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-23', 'studyFirstSubmitDate': '2011-01-09', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': '0-28 days', 'description': 'Number of hours required for positive pressure ventilation after the start of study drug'}], 'secondaryOutcomes': [{'measure': 'Improvement in oxygenation', 'timeFrame': '0-28 days', 'description': 'Differences in the PaO2/FiO2 ratios between the two randomized groups'}, {'measure': 'Incidence of nosocomial infections', 'timeFrame': '0-35 days', 'description': 'Infection surveillance will be in the form of tracheal aspirate for gram stain and culture done prior to study entry and then every 3-5 days. If a subject spikes a fever during the study drug infusion, they will have blood, urine and tracheal aspirate cultures done along with CBC and CRP. Number of nosocomial infections documented via surveillance cultures will be compared between groups.'}, {'measure': 'Incidence of hyperglycemia', 'timeFrame': '0-28 days', 'description': 'Number of times that the subject has a Blood Glucose \\>180 mg/dL (10 mmol/L) will be compared between the randomized groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['child', 'infant', 'lung injury', 'inflammation', 'pneumonia', 'ventilator'], 'conditions': ['Acute Respiratory Distress Syndrome (ARDS)', 'Acute Lung Injury (ALI)']}, 'referencesModule': {'references': [{'pmid': '27066464', 'type': 'DERIVED', 'citation': 'Kimura D, Saravia J, Rovnaghi CR, Meduri GU, Schwingshackl A, Cormier SA, Anand KJ. Plasma Biomarker Analysis in Pediatric ARDS: Generating Future Framework from a Pilot Randomized Control Trial of Methylprednisolone: A Framework for Identifying Plasma Biomarkers Related to Clinical Outcomes in Pediatric ARDS. Front Pediatr. 2016 Mar 31;4:31. doi: 10.3389/fped.2016.00031. eCollection 2016.'}, {'pmid': '26545141', 'type': 'DERIVED', 'citation': 'Schwingshackl A, Kimura D, Rovnaghi CR, Saravia JS, Cormier SA, Teng B, West AN, Meduri UG, Anand KJ. Regulation of inflammatory biomarkers by intravenous methylprednisolone in pediatric ARDS patients: Results from a double-blind, placebo-controlled randomized pilot trial. Cytokine. 2016 Jan;77:63-71. doi: 10.1016/j.cyto.2015.10.007. Epub 2015 Nov 3.'}, {'pmid': '25634565', 'type': 'DERIVED', 'citation': 'Drago BB, Kimura D, Rovnaghi CR, Schwingshackl A, Rayburn M, Meduri GU, Anand KJ. Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome. Pediatr Crit Care Med. 2015 Mar;16(3):e74-81. doi: 10.1097/PCC.0000000000000349.'}]}, 'descriptionModule': {'briefSummary': 'Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children.\n\nHypothesis:\n\nSubjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 1 month and 18 years of age; AND\n2. Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:\n\n 1. acute onset of the disease,\n 2. PaO2/FiO2 ratio \\<300,\n 3. evidence of bilateral infiltrates on chest radiography, and\n 4. no evidence of cardiac dysfunction; AND\n3. Intubated and mechanically ventilated.\n\nExclusion Criteria:\n\n1. Underlying disease requiring steroids \\>0.5mg/kg/day of methylprednisolone (eg. Asthma)\n2. HIV positive, or have any other congenital or acquired immunodeficiency;\n3. Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care\n4. Cytotoxic therapy within the past 3 weeks\n5. Major gastrointestinal bleeding within last 1 month\n6. Extensive burns (\\>20% total body surface area of full- or partial-thickness burns)\n7. Known or suspected adrenal insufficiency\n8. Vasculitis or diffuse alveolar hemorrhage\n9. Bone marrow or lung transplant\n10. Disseminated fungal infections\n11. Severe chronic liver disease\n12. Other conditions with estimated 6-month mortality of 50% or higher'}, 'identificationModule': {'nctId': 'NCT01274260', 'acronym': 'SPALIT', 'briefTitle': 'Trial of Steroids in Pediatric Acute Lung Injury/ARDS', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Steroids in Pediatic ALI/ARDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Group', 'description': 'Intervention: Subjects in this study group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.', 'interventionNames': ['Drug: methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Intervention: The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline. The placebo group with receive the masked study drug in infusion rates that mimic the infusions received by the experimental group.', 'interventionNames': ['Drug: Normal Saline (0.9%)']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'Subjects in this group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Normal Saline (0.9%)', 'type': 'DRUG', 'description': 'The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Le Bonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}