Remote Milk Collection for Breast Milk Research

Overseen By Katelyn Desorcy-Scherer, PhD, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Not meeting lactation goals, others

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a method for collecting breast milk from home to research gene expression, focusing on which genes are active and how they behave. Researchers are testing whether adding RNA preservation reagents to the milk helps maintain RNA integrity, which is crucial for analysis. Individuals who have been breastfeeding for at least four weeks, reside in Wisconsin, and are comfortable reading and speaking English may be suitable for this study. As an unphased study, this research allows participants to contribute to scientific understanding without the constraints of traditional clinical trial phases.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on collecting breast milk samples for research.

What prior data suggests that this protocol is safe for remote human milk collection?

Research has shown that collecting human milk can sometimes raise safety concerns, mainly due to contamination. Studies have found that milk bought online can contain bacteria and germs that cause disease. These issues typically occur with unscreened donors and improper handling.

This study focuses on collecting milk using special substances that protect RNA, a type of genetic material, to keep it intact for future research. Although specific safety data on this new method is not yet available, collecting human milk is a common practice. Following guidelines such as maintaining good hygiene and proper storage helps prevent contamination.

In summary, while this study employs a new technique, the basic practice of milk collection has established safety measures. Adhering to hygiene guidelines is crucial to keep the milk safe for research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Human Milk Collection trial because it offers a convenient and accessible way for lactating participants to contribute to breast milk research. Unlike traditional methods that require in-person visits to medical facilities, this remote approach allows participants to provide samples from the comfort of their own homes. This method not only broadens participation by reducing travel and time commitments but also has the potential to gather more diverse data, enhancing our understanding of human milk composition and its benefits.

What evidence suggests that this protocol is effective for preserving RNA in human milk?

Research has shown that technology can improve breastfeeding. For instance, one study found that live video calls with lactation experts increased the number of mothers exclusively breastfeeding in the first six months. Mobile apps have also boosted mothers' knowledge and confidence, leading to better breastfeeding outcomes. Online tools and support effectively educate and assist breastfeeding women. These findings suggest that using technology for remote human milk collection, as studied in this trial, could help maintain the high quality of milk samples. ^{2 6 7 8 9}

Who Is on the Research Team?

Katelyn Desorcy-Scherer, PhD, RN

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for lactating individuals who are willing to collect their breast milk and send it to a university for research. The study aims to include 50 participants.

Inclusion Criteria

I can speak and read English.

Lactating for greater than or equal to 4 weeks

Exclusion Criteria

Resides outside of Wisconsin

I am not meeting my breastfeeding goals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Evaluation

Participants collect human milk samples with RNA preservation reagents and send them to the university for RNA extraction and quality assessment.

1 year

Remote sample collection

Follow-up

Participants are monitored for feedback on sample collection feasibility and stress levels.

1 year

Data collected at time of sample return

What Are the Treatments Tested in This Trial?

Interventions

• Remote Human Milk Collection

Trial Overview The study is testing a new way of collecting human milk remotely by using RNA preservation reagents. This method could help in gene expression studies by ensuring that the RNA in the milk remains intact during shipping.

How Is the Trial Designed?

Group I: Lactating Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11934809/

The effectiveness of real-time telelactation intervention on ... The results showed that real-time telelactation services had a statistically significant positive effect on the EBF rate during the first six months compared ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017657/

Effectiveness of “Breast Milk Mother” Mobile Applications to ... The Breast Milk Mother mobile applications effectively improve knowledge, attitudes, breastfeeding timing, and breast milk adequacy for infants.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0277953614006893

Contextualizing online human milk sharing: Structural ... Differences in lactation sufficiency and breastfeeding outcomes between donors and recipients were associated with both structural and biocultural factors.

4. jmir.org jmir.org/2020/5/e17361/

Effectiveness of Internet-Based Electronic Technology ... This study demonstrated a variety of internet-based e-technologies that professionals can use to promote, educate, and support breastfeeding women.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397754/

Effectiveness of a Mobile Breastfeeding Monitoring Tool ... Maternal breastfeeding self-efficacy in the app-using group improved by an average of 1.36 (95% CI –3.79 to 1.50), while it declined slightly, by 0.16 (95% CI – ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4530303/

Microbial Contamination of Human Milk Purchased Via the ... Human milk purchased via the Internet exhibited high overall bacterial growth and frequent contamination with pathogenic bacteria.

7. publications.aap.org publications.aap.org/pediatrics/article/135/5/e1157/33631/Cow-s-Milk-Contamination-of-Human-Milk-Purchased

Cow's Milk Contamination of Human Milk Purchased via ... BACKGROUND:. The US Food and Drug Administration recommends against feeding infants human milk from unscreened donors, but sharing milk via the Internet.

8. researchgate.net researchgate.net/publication/373928992_Citation_S_Sarkar_Safety_Of_Donor_Human_Milk

(PDF) Citation: S. Sarkar. Safety Of Donor Human Milk to all new donors covering the following aspects [18]. • Hand washing and the importance of milk donation. • Good personal hygiene practices. • Collecting and ...

9. fda.gov fda.gov/science-research/pediatrics/use-donor-human-milk

Use of Donor Human Milk HMBANA issues voluntary safety guidelines for member banks on screening donors, and collecting, processing, handling, testing and storing milk.