Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT07268105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Control Trial of Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight of milk', 'timeFrame': 'Maximum participation is 3 weeks', 'description': 'The weight of the milk will be collected. A food grade scale will be used.'}], 'secondaryOutcomes': [{'measure': 'Pumping satisfaction', 'timeFrame': 'Maximum participation in 3 weeks.', 'description': 'Satisfaction with use of the pump will be collected with a validated measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human milk, breastfeeding, NICU, Breast pump'], 'conditions': ['Human Milk/Breastfeeding', 'Breast Pumping']}, 'referencesModule': {'references': [{'pmid': '22834882', 'type': 'RESULT', 'citation': 'Purdy IB, Singh N, Le C, Bell C, Whiteside C, Collins M. Biophysiologic and social stress relationships with breast milk feeding pre- and post-discharge from the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):347-57. doi: 10.1111/j.1552-6909.2012.01368.x.'}, {'pmid': '23867708', 'type': 'RESULT', 'citation': "Alves E, Rodrigues C, Fraga S, Barros H, Silva S. Parents' views on factors that help or hinder breast milk supply in neonatal care units: systematic review. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F511-7. doi: 10.1136/archdischild-2013-304029. Epub 2013 Jul 18."}, {'pmid': '35062895', 'type': 'RESULT', 'citation': "Anders LA, Robinson K, Ohlendorf JM, Hanson L. Unseen, unheard: a qualitative analysis of women's experiences of exclusively expressing breast milk. BMC Pregnancy Childbirth. 2022 Jan 21;22(1):58. doi: 10.1186/s12884-022-04388-6."}, {'pmid': '35921640', 'type': 'RESULT', 'citation': 'Meek JY, Noble L; Section on Breastfeeding. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics. 2022 Jul 1;150(1):e2022057988. doi: 10.1542/peds.2022-057988.'}, {'pmid': '29427014', 'type': 'RESULT', 'citation': 'Lau CYK, Lok KYW, Tarrant M. Breastfeeding Duration and the Theory of Planned Behavior and Breastfeeding Self-Efficacy Framework: A Systematic Review of Observational Studies. Matern Child Health J. 2018 Mar;22(3):327-342. doi: 10.1007/s10995-018-2453-x.'}]}, 'descriptionModule': {'briefSummary': 'Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents. Flanges are the part of the pump that fits over the breast and through suction, pulls on the nipple to extract the milk. Recent research showed that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies.\n\nWe hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.\n\nWe are conducting a randomized control trial to explore whether the Flange FITS process is better than the standard (manufacturers instructions) for breastpump flange fitting for new parents who are pumping their milk for their newborns in the NICU. We will randomize (1:1) participants to either the new type of flange fitting (Flange FITS) or usual standard care. The study team will assist the pumping parent participant with flange fitting according to their group. This study will ask the pumping parent participants for information about their child and their experience with pumping, and requests that they record the weight of their breast milk after each pump while in the study. The participants already have the pumps and flanges as part of their standard of care. The researchers will provide participants with a scale to weight their breastmilk after each pump while int he study. The researchers will not go into the medical record to retrieve information for the purposes of the study; all information collected for the study will come from the pumping parent participant.', 'detailedDescription': 'Recent research shows that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies. https://www.babiesincommon.com/flange-fits-guide Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents.\n\nIn this study we will 1:1 randomize lactating people with neonates in the NICU to the experimental group (Flange FITS Guide sizing method) or the control group (flange manufacturers sizing guide).\n\nWe hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.\n\nAims:\n\n1. Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.\n2. Determine in there is an increase in comfort with breastfeeding, breastfeeding satisfaction, length of pumping with the use of the Flange FITS TM Guide sizing method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have newborn in NICU\n* Using a breast pump Ability to pump 6-8 times a day\n\nExclusion Criteria:\n\n* Not using a breast pump No newborn in the NICU'}, 'identificationModule': {'nctId': 'NCT07268105', 'briefTitle': 'Randomized Control Trial of Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Randomized Control Trial of Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction', 'orgStudyIdInfo': {'id': 'HP-00114021'}, 'secondaryIdInfos': [{'id': 'HP-00114021', 'type': 'OTHER', 'domain': 'University of Maryland, Baltimore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control/usual care', 'description': 'Pumping people will be provided the usual education and flange fitting procedures.', 'interventionNames': ['Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'This groups will receive the FLANGEFITS protocol.', 'interventionNames': ['Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.']}], 'interventions': [{'name': 'The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.', 'type': 'OTHER', 'description': 'The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.', 'armGroupLabels': ['Control/usual care', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Rachel B Breman, PhD, MPH, RN', 'role': 'CONTACT', 'email': 'rbreman@umaryland.edu', 'phone': '301-503-9433'}, {'name': 'Hannah McGraw, MSN, RN', 'role': 'CONTACT', 'email': 'hannah.mcgraw@umm.edu', 'phone': '4103107667'}, {'name': 'Rachel B Breman, PhD, MPH, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Rachel B Breman, PhD, MPH, RN', 'role': 'CONTACT', 'email': 'rbreman@umaryland.edu', 'phone': '3015039433'}, {'name': 'Hannah McGraw, MSN, RN', 'role': 'CONTACT', 'email': 'hannah.mcgraw@umm.edu', 'phone': '4103107667'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a small internal grant. We also need to protect the privacy of participants. We plan to publish results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}