Flange Fitting for Breast Pumping

Overseen By Hannah McGraw, MSN, RN

Age: 18+

Sex: Female

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for fitting breast pump flanges, called the Flange FITS Guide, to determine if it helps parents of babies in the NICU (Neonatal Intensive Care Unit) produce more milk and improve their pumping experience. The trial compares this method to the usual fitting instructions provided with breast pumps. Participants will either use the new Flange FITS method or follow standard care, recording the weight of their milk after each pumping session. This trial suits parents with a newborn in the NICU who use a breast pump at least 6-8 times a day. As a Phase 4 trial, the Flange FITS Guide has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on breast pump flange fitting, so it's unlikely that your medications would be affected, but you should confirm with the study team.

What is the safety track record for the FLANGEFits Protocol?

Research shows that the new method for fitting breast pump flanges, known as the Flange FITS TM Guide sizing method, has promising results. Studies have found that it increases milk output and enhances comfort for parents. This method emphasizes selecting the correct flange size, which fits over the breast and pulls on the nipple to extract milk, ensuring both comfort and efficiency.

There are no known risks associated with this method. The primary goal is to improve comfort and milk flow. As a Phase 4 study, this method has already undergone testing in earlier phases and is considered safe. Participants in those trials reported no major side effects.

Overall, the Flange FITS method appears well-tolerated, with increased milk production and improved comfort during pumping as the main benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FLANGEFits Protocol for breast pumping because it aims to enhance comfort and efficiency, which are crucial for new parents. Unlike standard care, which often involves a one-size-fits-all approach to flange fitting, this protocol offers a tailored fit, potentially reducing discomfort and improving milk extraction efficiency. By focusing on personalized adjustments, the FLANGEFits Protocol could lead to better outcomes for lactating individuals, making the breastfeeding process smoother and more effective.

What evidence suggests that the Flange FITS protocol is effective for NICU parents?

Research shows that the Flange FITS TM Guide sizing method can significantly increase milk production and enhance comfort during pumping. One study found that using the Flange FITS method resulted in higher comfort levels and increased milk output compared to standard methods. Participants consistently reported better results with this method. This suggests that properly fitted flanges might help in obtaining more milk and improving the overall pumping experience. In the current trial, participants in the intervention group will receive the FLANGEFITS protocol to test its effectiveness for parents with babies in the NICU, a group not previously studied. Meanwhile, the control group will receive usual care and standard flange fitting procedures. ^{1 2 6 7 8}

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07268105

Randomized Control Trial of Flange Fitting for NICU ...

Recent research showed that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and ...

2.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/08903344241296036

Flange Size Matters: A Comparative Pilot Study of the ...

Smaller-fit sizing, determined using the Flange FITSTM Guide, led to significantly higher self-reported comfort and, on average, more milk ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39614713/

Flange Size Matters: A Comparative Pilot Study of the ...

Participants pumped for 1 week with each set of flanges and recorded milk output and comfort outcome measures. Data were collected on participant demographics, ...

4.

researchgate.net

researchgate.net/publication/398317353_Perspectives_on_Breast_Pump_Experiences_Findings_from_a_US_National_Cross-Sectional_Survey

Findings from a U.S. National Cross-Sectional Survey

While electric breast pumps promise women convenience and efficiency in pumping, women may incur personal costs, in the form of pain, injuries, ...

5.

abaprofessional.asn.au

abaprofessional.asn.au/flange-size-matters-a-comparative-pilot-study-of-the-flange-fitstm-guide-versus-traditional-sizing-methods/

Flange size matters: A comparative pilot study of the Flange ...

When expressing, the fit of the breast pump flange is important for the mother's comfort and to optimise milk output. However, guidance for ...

6.

researchgate.net

researchgate.net/publication/362661578_Flange_Sizing_Recommendations_for_Frequent_Breast_Pump_Use

Flange Sizing Recommendations for Frequent Breast ...

Objective: There is a lack of evidence or practice guidelines surrounding safe and effective breast pump use. Many lactation personnel feel ...

7.

genuinelactation.com

genuinelactation.com/blog-for-breastfeeding-families/flange-sizing-what-does-the-data-say

Flange Sizing- What Does the Data Say?

This updated data set included an additional 700 clients sizing assessments and showed the trend supports the smaller sizing resulting in comfortable and ...

8.

discovery.researcher.life

discovery.researcher.life/article/flange-sizing-recommendations-for-frequent-breast-pump-use/ab4e6351596e31b4b52fdec7ac7ba13a

Flange Sizing Recommendations for Frequent Breast Pump Use

Clinical Lactation; Alisa Williams. Objective:There is a lack of evidence or practice guidelines surrounding safe and effective breast pump use.