Nctid:
NCT06222567
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D001566", "term"=>"Benzocaine"}], "ancestors"=>[{"id"=>"D000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000777", "term"=>"Anesthetics"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M4854", "name"=>"Benzocaine", "asFound"=>"Proposal", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "asFound"=>"Proposal", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>90}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-02-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-08-18", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-08-18", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Total expression volume in milliliter", "timeFrame"=>"T1= 15 minutes, T2=20 minutes"}], "secondaryOutcomes"=>[{"measure"=>"Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4)", "timeFrame"=>"T1= 15 minutes, T2=20 minutes"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Breast Pumping"]}, "descriptionModule"=>{"briefSummary"=>"The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.", "detailedDescription"=>"This study aims to assess if expression milk volume could be improved for patients pumping milk for a clinical indication by implementing five minutes more pumping with the MAINTAIN program, a different sucking pattern, to initiate and benefit milk production. The results of this study will provide important information that validates the proposed changes as well as build clear recommendation for using the Symphony program cards in this population."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Subject ≥ 18 years old\n* Infant was born maximum 4 (96 hours) days ago\n* Subject aims to provide breastmilk for the baby through breastfeeding.\n* At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.\n* Subject has an clinical indication to pump for reasons\n* The subject signs the informed consent documentation\n\nExclusion Criteria:\n\n* Woman is exclusively pumping\n* Woman is still breastfeeding with the previous child\n* Woman has been breastfeeding in the last 6 months"}, "identificationModule"=>{"nctId"=>"NCT06222567", "briefTitle"=>"Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery", "organization"=>{"class"=>"OTHER", "fullName"=>"Onze Lieve Vrouwe Gasthuis"}, "officialTitle"=>"Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.", "orgStudyIdInfo"=>{"id"=>"OLVG040"}, "secondaryIdInfos"=>[{"id"=>"WO 22.168", "type"=>"OTHER", "domain"=>"OLVG"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Pumping individual", "description"=>"Clinical indication for pumping", "interventionNames"=>["Device: 15 minutes pumping with INITIATE program", "Device: 5 minutes extra pumping with MAINTAIN program"]}], "interventions"=>[{"name"=>"15 minutes pumping with INITIATE program", "type"=>"DEVICE", "description"=>"15 minutes pumping with INITIATE program", "armGroupLabels"=>["Pumping individual"]}, {"name"=>"5 minutes extra pumping with MAINTAIN program", "type"=>"DEVICE", "description"=>"Additional 5 minutes extra pumping with MAINTAIN program", "armGroupLabels"=>["Pumping individual"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Amsterdam", "country"=>"Netherlands", "facility"=>"OLVG Hospital", "geoPoint"=>{"lat"=>52.37403, "lon"=>4.88969}}], "overallOfficials"=>[{"name"=>"Fedde Scheele, Prof. Dr.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"OLVG Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Individual data is not shared"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Onze Lieve Vrouwe Gasthuis", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Medela AG", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
