Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
NCT ID: NCT07268105
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
124 participants
INTERVENTIONAL
2025-12-01
2027-07-02
Brief Summary
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We 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.
We 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.
Detailed Description
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In 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).
The investigators 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.
Aims:
1. Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Control/usual care
Pumping people will be provided the usual education and flange fitting procedures.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
Intervention group
This groups will receive the FLANGEFITS protocol.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
Interventions
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The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
Eligibility Criteria
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Inclusion Criteria
* Using a breast pump Ability to pump 6-8 times a day
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Rachel B Breman, PhD, MPH, RN
Role: primary
Hannah McGraw, MSN, RN
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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HP-00114021
Identifier Type: OTHER
Identifier Source: secondary_id
HP-00114021
Identifier Type: -
Identifier Source: org_study_id