MedTrace Logo

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

NCT07268105 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Human Milk/Breastfeeding
  • Breast Pumping

Interventions

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-01-02
Completion
2027-07-02

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268105 on ClinicalTrials.gov