An interventional study of The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. in Human Milk/Breastfeeding and Breast Pumping, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Other
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.
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.
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.
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:
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Exclusion Criteria:
Pumping people will be provided the usual education and flange fitting procedures.
Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
This groups will receive the FLANGEFITS protocol.
Other: 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.
Weight of milk
The weight of the milk will be collected. A food grade scale will be used.
Time frame: Maximum participation is 3 weeks
Pumping satisfaction
Satisfaction with use of the pump will be collected with a validated measure.
Time frame: Maximum participation in 3 weeks.
Plan to share: No — This is a small internal grant. We also need to protect the privacy of participants. We plan to publish results.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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