Flange Fitting for Breast Pumping

Overseen By Hannah McGraw, MSN, RN

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Disqualifiers: Not using breast pump, No NICU newborn

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for new parents in the NICU who are using breast pumps to feed their newborns. Participants should be currently pumping and willing to follow study protocols, including weighing their milk after each pump.

Inclusion Criteria

Have newborn in NICU

Using a breast pump with the ability to pump 6-8 times a day

Exclusion Criteria

Not using a breast pump

No newborn in the NICU

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to either the Flange FITS Guide sizing method or the standard flange fitting method and will record the weight of their breast milk after each pump

3 weeks

Ongoing self-monitoring and data collection

Follow-up

Participants are monitored for satisfaction and effectiveness of the flange fitting method after the treatment phase

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FLANGEFits Protocol

Trial Overview The study tests the Flange FITS TM Guide sizing method against standard manufacturer instructions for fitting breast pump flanges. It aims to see if this new method can increase milk output and improve the pumping experience.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

This groups will receive the FLANGEFITS protocol.

Group II: Control/usual care Active Control 1 Intervention

Pumping people will be provided the usual education and flange fitting procedures.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+