Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04619212
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 different groups, where 1 group does SoC (comparator device), the second uses the new device.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events', 'timeFrame': 'during the 20 minutes pumping procedure. this is the only visit and task for the patient.', 'description': 'Number of patients with adverse events \\& description'}, {'measure': 'Comfort while pumping', 'timeFrame': 'Within the 20 minutes pumping procedure. this is the only visit and task for the patient.', 'description': 'Assessed by the necessity of reducing the vacuum strength during pumping (binary outcome). It is expected that mothers should not need to change the vacuum strength when using the new program card'}], 'secondaryOutcomes': [{'measure': 'Performance of the new software', 'timeFrame': 'during the 20 minutes pumping procedure. this is the only visit and task for the patient.', 'description': 'The output milk volume will be measured between the standard of care (pumping) approach and the new program card INITIATE 2.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Pumping']}, 'referencesModule': {'references': [{'pmid': '41276904', 'type': 'DERIVED', 'citation': 'Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study. J Perinat Neonatal Nurs. 2025 Nov 24. doi: 10.1097/JPN.0000000000000975. Online ahead of print.'}, {'pmid': '38707635', 'type': 'DERIVED', 'citation': 'Manshanden TMN, Prime DK, Scheele F, Velzel J. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study. Front Glob Womens Health. 2024 Apr 19;5:1378263. doi: 10.3389/fgwh.2024.1378263. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.', 'detailedDescription': 'This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only women can produce human milk', '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 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 experiencing a mastitis event\n* Woman is still breastfeeding with the previous child\n* Woman has been breastfeeding in the last 6 months\n* Woman received morphine pain medication in the last 8 hours'}, 'identificationModule': {'nctId': 'NCT04619212', 'acronym': 'Initiate', 'briefTitle': 'Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medela AG'}, 'officialTitle': 'A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.', 'orgStudyIdInfo': {'id': 'MHM_2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Standard of Care', 'interventionNames': ['Device: breast pumping as per SoC but on new software for the pump']}, {'type': 'OTHER', 'label': 'new device', 'description': 'new device', 'interventionNames': ['Device: breast pumping as per SoC but on new software for the pump']}], 'interventions': [{'name': 'breast pumping as per SoC but on new software for the pump', 'type': 'DEVICE', 'description': 'breast pumping as per SoC but on new software for the pump', 'armGroupLabels': ['Standard of Care', 'new device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1091', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Fedde Scheele', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study team'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual data is not shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medela AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}