Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
Public ClinicalTrials.gov record NCT07268105. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07268105
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jul 1, 2027
- Last update posted
- Mar 16, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07268105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07268105 live on ClinicalTrials.gov.