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Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction

Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07268105
Enrollment
0
Registered
2025-12-05
Start date
2026-03-01
Completion date
2027-07-02
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pumping, Human Milk/Breastfeeding

Keywords

breast pump, human milk

Brief summary

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.

Detailed description

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: 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.

Interventions

OTHERThe 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.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

The intervention is the type of fitting provided for using the pump. Usual fitting versus the FLANGEFITs protocol.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have newborn in NICU * Using a breast pump Ability to pump 6-8 times a day

Exclusion criteria

* Not using a breast pump No newborn in the NICU

Design outcomes

Primary

MeasureTime frameDescription
Weight of milkMaximum participation is 3 weeksThe weight of the milk will be collected. A food grade scale will be used.

Secondary

MeasureTime frameDescription
Pumping satisfactionMaximum participation in 3 weeks.Satisfaction with use of the pump will be collected with a validated measure.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026