MILC Application for Exclusive Breastfeeding

(MILC Trial)

Not yet recruiting at 2 trial locations

Overseen By Katie Chang, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Benten Technologies, Inc.

Must not be taking: Antiretrovirals, Chemotherapy, Radiation, others

Disqualifiers: HIV, Tuberculosis, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new app called MILC, designed to support Hispanic women in exclusive breastfeeding. The app provides a combination of professional advice and community support to help mothers breastfeed their babies for up to 12 months. Hispanic women in their late third trimester who receive WIC benefits and own a smartphone might be a good fit. Participants will join either a group using the MILC app or a group receiving usual care.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance breastfeeding support for Hispanic women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking antiretroviral medication, chemotherapy agents, or any prescription drugs that are incompatible with breastfeeding.

What prior data suggests that the MILC application is safe for use in breastfeeding support?

Research shows that digital tools like the MILC app can greatly aid breastfeeding. Although specific safety data for the MILC app is unavailable, these tools typically focus on education and support rather than medical treatment. As a result, they are generally safe since they don't involve medicine or physical procedures.

The MILC app provides personalized breastfeeding advice and support, particularly for Hispanic women. By offering information and fostering community, it usually poses no physical side effects. It's similar to using a health app on a phone that provides tips and reminders.

Overall, the goal is to assist mothers with breastfeeding without introducing medical risks. For those considering joining this trial, it likely offers a safe way to gain additional support and information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MILC application because it offers a novel approach to supporting exclusive breastfeeding among Hispanic mothers. Unlike standard breastfeeding support services provided by programs like WIC, the MILC application integrates digital tools to enhance accessibility and engagement for expectant mothers in their third trimester. This technology-driven method aims to provide personalized and continuous support, potentially leading to better breastfeeding outcomes and increased rates of exclusive breastfeeding, which is crucial for infant health.

What evidence suggests that the MILC application is effective for exclusive breastfeeding?

Research has shown that mobile apps like the MILC app, which participants in this trial may use, can ease breastfeeding for mothers. One study found that these apps improve mothers' knowledge, attitudes, and breastfeeding habits, such as timing and quantity. Another study found that mobile apps enhance the overall breastfeeding experience for mothers. Additionally, access to lactation consultants and breastfeeding support encourages more mothers to start and continue breastfeeding. These findings suggest that the MILC app could effectively help low-income Hispanic women breastfeed exclusively. ^{1 3 6 7 8}

Who Is on the Research Team?

Tony Ma, MS

Principal Investigator

Benten Technologies

Yukiko Washio, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

This trial is for low-income Hispanic mothers who are currently breastfeeding or planning to breastfeed. It aims to help them overcome breastfeeding challenges using a mobile app called MILC, which offers professional and social support along with personalized education.

Inclusion Criteria

* Mothers who successfully exclusively breastfed for up to 6 months, at least one child OR mothers who attempted EBF but were unsuccessful at breastfeeding, in the past 3 years

* Self-identify as Hispanic

* Be WIC-eligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MILC application along with standard WIC services

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for breastfeeding rates and app usability

6 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• MILC Application

Trial Overview

The study is testing the effectiveness of the MILC application in promoting exclusive and any breastfeeding behaviors compared to usual care methods. The app provides a network of support tailored specifically for Hispanic women.

How Is the Trial Designed?

Group I: Intervention group: MILC application Experimental Treatment 1 Intervention

Eligible Hispanic participants in their third trimester will be recruited for the study. The intervention group will receive standard WIC services plus the MILC application.

Group II: Control Group: Usual Care Experimental Treatment 1 Intervention

Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.

Who Is Running the Clinical Trial?

Benten Technologies, Inc.

Lead Sponsor

Trials

5

Recruited

2,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Published Research Related to This Trial

A study analyzing 100 queries from health professionals about drug safety during breastfeeding found that 59% of the evaluated drugs were deemed safe for breastfeeding, indicating that many medications can be used without requiring mothers to stop breastfeeding.

The most frequently asked about drugs included lamotrigine, codeine, quetiapine, and escitalopram, highlighting a particular concern among healthcare providers regarding the safety of medications affecting the nervous system during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres. Jahnsen, JA., Widnes, SF., Schjøtt, J.[2022]

A study identified 41 adverse event reports related to breast pumps from 1992 to 2003, highlighting issues such as pain, soreness, and breast tissue damage, particularly with electric pumps.

The findings suggest that adverse events, including contamination of breast milk and infections from manual pumps, are likely underreported, emphasizing the need for better reporting to enhance breast pump safety and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast pump adverse events: reports to the food and drug administration. Brown, SL., Bright, RA., Dwyer, DE., et al.[2018]

Exclusive breastfeeding for the first 6 months is strongly supported by the nutritional and immunologic benefits of human milk, which lead to better health outcomes for both mothers and infants.

Clinicians need to recognize normal breastfeeding patterns and identify common challenges in the early days post-birth to support successful lactation and minimize the need for supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Updates on the First Week of Exclusive Breastfeeding Among Infants ≥35 Weeks. Feldman-Winter, L., Kellams, A., Peter-Wohl, S., et al.[2020]

The FDA hosted a 2-day workshop focused on the safety of medications used by breastfeeding mothers, aiming to gather data on potential risks to infants.

The discussions emphasized the need for improved data collection methods and future clinical studies to better understand the effects of maternal medication use during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. Wang, J., Johnson, T., Sahin, L., et al.[2018]

The new ultraconcentrated liquid human milk fortifier (LHMF) significantly improved growth metrics, such as weight and length, in preterm infants compared to a traditional powdered human milk fortifier (HMF) over a 28-day study involving 150 infants.

The LHMF was found to be safe, with no increase in the incidence of serious conditions like sepsis or necrotizing enterocolitis, while also providing about 20% more protein than the control HMF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new liquid human milk fortifier and linear growth in preterm infants. Moya, F., Sisk, PM., Walsh, KR., et al.[2012]

The demand for lactation support in primary care has risen, highlighting the importance of pediatric nurse practitioners who can assess both newborns and breastfeeding mothers.

Key factors for successful breastfeeding include good infant weight gain, maternal comfort, and achieving a proper latch, which are essential for effective lactation consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lactation consult: problem solving, teaching, and support for the breastfeeding family. Dann, MH.[2007]

Citations

1.

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.

2.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2832390

Interventions to Support Breastfeeding: Updated Evidence ...

There was limited and mixed evidence on the effectiveness of breastfeeding support interventions on infant health outcomes (10 trials [n = 6592]) ...

3.

i-jmr.org

i-jmr.org/2025/1/e70098

Lactation Consultant Access and Breastfeeding Outcomes ...

Breastfeeding outcome data included initiation, exclusive breastfeeding at 3 months, and exclusive breastfeeding at 6 months. Simple and ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0882596323003305

Development of a mobile application -based breastfeeding ...

As a result of the research, it was determined that the mobile application-based breastfeeding program positively affected the mothers' breastfeeding experience ...

5.

cdc.gov

cdc.gov/breastfeeding-data/mpinc/supporting-evidence.html

mPINC™ Survey Supporting Evidence | Breastfeeding Data

These outcomes include improved breastfeeding initiation, breastfeeding exclusivity, and breastfeeding duration.1-4. Results also show a dose-response ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK487814/

Executive summary - Guideline: Protecting, Promoting ... - NCBI

The World Health Organization (WHO) recommends exclusive breastfeeding for the first 6 months of life, followed by continued breastfeeding with appropriate ...

7.

publications.aap.org

publications.aap.org/pediatrics/article/150/1/e2022057988/188347/Policy-Statement-Breastfeeding-and-the-Use-of

Policy Statement: Breastfeeding and the Use of Human Milk

Exclusive Breastfeeding​​ Human milk has a unique composition, with antimicrobial, antiinflammatory, immunoregulatory agents, and living ...

8.

who.int

who.int/tools/elena/interventions/exclusive-breastfeeding

Exclusive breastfeeding for optimal growth, development ...

Infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health.