Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-28 @ 4:40 AM
Study NCT ID:
NCT02128867
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Airway Clearance Techniques in Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'filip.vanginderdeuren@uzbrussel.be', 'phone': '+3224763916', 'title': 'filip van ginderdeuren', 'organization': 'vrije universiteit brussel'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Assisted Autogenic Drainage (AAD)', 'description': 'airway clearance technique for infants :Assisted Autogenic Drainage\n\nAssisted Autogenic Drainage (AAD)', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bouncing Combined With AAD', 'description': 'airway clearance technique for infants : bouncing combined with AAD\n\nbouncing combined with AAD', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bouncing', 'description': 'bouncing as control group. intervention to relax the infant\n\nbouncing', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Refluxes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Assisted Autogenic Drainage (AAD)', 'description': 'airway clearance technique for infants :Assisted Autogenic Drainage\n\nAssisted Autogenic Drainage (AAD)'}, {'id': 'OG001', 'title': 'Bouncing Combined With AAD', 'description': 'airway clearance technique for infants : bouncing combined with AAD\n\nbouncing combined with AAD'}, {'id': 'OG002', 'title': 'Bouncing', 'description': 'bouncing as control group. intervention to relax the infant\n\nbouncing'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'number of refluxes will be counted over a period of 15 minutes ( treatment time )', 'unitOfMeasure': 'number of refluxes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Reflux Episodes', 'timeFrame': '15 minutes', 'description': 'duration of reflux episodes will be measured during 15 min of treatment time', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heartrate', 'timeFrame': '15 minutes', 'description': 'heartrate will be measured during 15 min of treatment time', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sa02', 'timeFrame': '15 minutes', 'description': 'SaO2 will be measured during 15 minutes of treatment time', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Assisted Autogenic Drainage (AAD)', 'description': 'airway clearance technique for infants :Assisted Autogenic Drainage\n\nAssisted Autogenic Drainage (AAD)'}, {'id': 'FG001', 'title': 'Bouncing Combined With AAD', 'description': 'airway clearance technique for infants : bouncing combined with AAD\n\nbouncing combined with AAD'}, {'id': 'FG002', 'title': 'Bouncing', 'description': 'bouncing as control group. intervention to relax the infant\n\nbouncing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Assisted Autogenic Drainage (AAD)', 'description': 'airway clearance technique for infants :Assisted Autogenic Drainage\n\nAssisted Autogenic Drainage (AAD)'}, {'id': 'BG001', 'title': 'Bouncing Combined With AAD', 'description': 'airway clearance technique for infants : bouncing combined with AAD\n\nbouncing combined with AAD'}, {'id': 'BG002', 'title': 'Bouncing', 'description': 'bouncing . intervention to relax the infant\n\nbouncing'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2014-04-23', 'resultsFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-10', 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heartrate', 'timeFrame': '15 minutes', 'description': 'heartrate will be measured during 15 min of treatment time'}, {'measure': 'Sa02', 'timeFrame': '15 minutes', 'description': 'SaO2 will be measured during 15 minutes of treatment time'}], 'primaryOutcomes': [{'measure': 'Number of Refluxes', 'timeFrame': '15 minutes', 'description': 'number of refluxes will be counted over a period of 15 minutes ( treatment time )'}], 'secondaryOutcomes': [{'measure': 'Duration of Reflux Episodes', 'timeFrame': '15 minutes', 'description': 'duration of reflux episodes will be measured during 15 min of treatment time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastro-esophageal reflux', 'GOR', 'GER', 'airway clearance techniques'], 'conditions': ['Gastro-esophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '365 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants \\< 1 year\n* acid reflux monitoring\n\nExclusion Criteria:\n\n* gestational age \\<24 w\n* anti-reflux medication\n* Nissen fundoplication\n* no parental consent'}, 'identificationModule': {'nctId': 'NCT02128867', 'briefTitle': 'Safety Study of Airway Clearance Techniques in Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months', 'orgStudyIdInfo': {'id': 'FVG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assisted Autogenic Drainage (AAD)', 'description': 'airway clearance technique for infants :Assisted Autogenic Drainage', 'interventionNames': ['Other: Assisted Autogenic Drainage (AAD)']}, {'type': 'EXPERIMENTAL', 'label': 'bouncing and AAD', 'description': 'airway clearance technique for infants : bouncing combined with AAD', 'interventionNames': ['Other: bouncing and AAD']}, {'type': 'EXPERIMENTAL', 'label': 'bouncing', 'description': 'bouncing . intervention to relax the infant', 'interventionNames': ['Other: bouncing']}], 'interventions': [{'name': 'Assisted Autogenic Drainage (AAD)', 'type': 'OTHER', 'armGroupLabels': ['Assisted Autogenic Drainage (AAD)']}, {'name': 'bouncing and AAD', 'type': 'OTHER', 'armGroupLabels': ['bouncing and AAD']}, {'name': 'bouncing', 'type': 'OTHER', 'armGroupLabels': ['bouncing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZBrussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, Drs.', 'investigatorFullName': 'Filip Van Ginderdeuren', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}