Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00435994
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2007-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D017817', 'term': 'Nasal Lavage Fluid'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D055556', 'term': 'Nasal Lavage'}, {'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rtepper@iu.edu', 'phone': '317-274-9647', 'title': 'Robert Tepper, MD, Ph.D.', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'More than half of our infants woke up before completion of the protocol therefore limiting our analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Control', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Respiratory Syncytial Virus', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bronchiolitis', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.'}, {'id': 'OG001', 'title': 'Respiratory Syncytial Virus', 'description': 'Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.071', 'spread': '0.586', 'groupId': 'OG000'}, {'value': '-3.179', 'spread': '2.610', 'groupId': 'OG001'}]}]}, {'title': 'Post Bronchodilator', 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.639', 'groupId': 'OG000'}, {'value': '-3.345', 'spread': '2.112', 'groupId': 'OG001'}]}]}, {'title': 'Post Epinephrine', 'categories': [{'measurements': [{'value': '0.041', 'spread': '0.802', 'groupId': 'OG000'}, {'value': '-2.430', 'spread': '2.716', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)', 'description': 'Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.', 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.'}, {'type': 'PRIMARY', 'title': 'Endothelial Growth Factor (VEGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity'}, {'id': 'OG001', 'title': 'Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only', 'description': 'Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.'}], 'classes': [{'categories': [{'measurements': [{'value': '183.526', 'spread': '223.268', 'groupId': 'OG000'}, {'value': '568.867', 'spread': '407.257', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0020', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During nasal wash', 'description': 'Analysis for VEGF level by ELISA', 'unitOfMeasure': 'pg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Control', 'description': 'Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity'}, {'id': 'FG001', 'title': 'Respiratory Syncytial Virus', 'description': 'Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI'}, {'id': 'FG002', 'title': 'Bronchiolitis-Nasal Wash Only', 'description': 'Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '7 of the subjects were consented and did not complete the study procedures.', 'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Control', 'description': 'Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity'}, {'id': 'BG001', 'title': 'Respiratory Syncytial Virus', 'description': 'Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI'}, {'id': 'BG002', 'title': 'Bronchiolitis', 'description': 'Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '5', 'groupId': 'BG000'}, {'value': '7', 'spread': '6', 'groupId': 'BG001'}, {'value': '7', 'spread': '4', 'groupId': 'BG002'}, {'value': '11', 'spread': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2007-01-25', 'resultsFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2007-02-15', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-23', 'studyFirstPostDateStruct': {'date': '2007-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Function', 'timeFrame': 'Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)', 'description': 'Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.'}, {'measure': 'Endothelial Growth Factor (VEGF)', 'timeFrame': 'During nasal wash', 'description': 'Analysis for VEGF level by ELISA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infant', 'Respiratory Syncytial Virus', 'Bronchiolitis'], 'conditions': ['Bronchiolitis', 'Respiratory Syncytial Virus Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.', 'detailedDescription': 'We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1 Infants between 2 and 24 months that are healthy\n* Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing\n\nExclusion Criteria:\n\n* Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \\< 37 weeks, and cannot be in the ICU.'}, 'identificationModule': {'nctId': 'NCT00435994', 'briefTitle': 'Assessment of Airway Obstruction in Infants With Lower Respiratory Infections', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Assessment of Airway Obstruction in Infants With Lower Respiratory Infections', 'orgStudyIdInfo': {'id': '0311-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Infants with viral lower respiratory infections', 'description': 'Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants', 'interventionNames': ['Drug: Inhaled primatene will be given as a breathing treatment', 'Other: Nasal Washing']}, {'type': 'OTHER', 'label': 'Healthy Control', 'description': 'Healthy infants between the ages of 2-24 month', 'interventionNames': ['Drug: Inhaled primatene will be given as a breathing treatment', 'Other: Nasal Washing']}, {'type': 'OTHER', 'label': 'Bronchiolitis-Nasal wash only', 'description': 'Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only', 'interventionNames': ['Other: Nasal Washing']}], 'interventions': [{'name': 'Inhaled primatene will be given as a breathing treatment', 'type': 'DRUG', 'otherNames': ['epinephrine 0.5ml of the 2.25% concentration'], 'description': 'While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.', 'armGroupLabels': ['Healthy Control', 'Infants with viral lower respiratory infections']}, {'name': 'Nasal Washing', 'type': 'OTHER', 'description': "1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence", 'armGroupLabels': ['Bronchiolitis-Nasal wash only', 'Healthy Control', 'Infants with viral lower respiratory infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Robert S. Tepper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}