Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06222567
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2024-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}], 'ancestors': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, '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': '2025-01', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-24', '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', 'description': 'Expressed milk volume in milliliters between 15 and 20 minutes of pumping'}], 'secondaryOutcomes': [{'measure': 'Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4) and patient characteristic. Milk yielded in milliliters per minute after 15 and 20 minutes pumping.', 'timeFrame': 'T1= 15 minutes, T2=20 minutes'}]}, 'oversightModule': {'isUsExport': False, '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 has an clinical indication to pump for reasons\n* The subject signs the informed consent documentation'}, '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'}}}}