MILC Application for Exclusive Breastfeeding

(MILC Trial)

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

178 Participants Needed

Trial Summary

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 data supports the effectiveness of the MILC Application treatment for exclusive breastfeeding?

The research highlights the importance of lactation consultation and support in improving breastfeeding outcomes, suggesting that similar supportive measures, like the MILC Application, could be effective in promoting exclusive breastfeeding. ^{1 2 3 4 5}

Is the MILC Application for Exclusive Breastfeeding safe for humans?

There is no specific safety data available for the MILC Application for Exclusive Breastfeeding. However, related studies on breastfeeding devices and medications used during lactation highlight the importance of monitoring for potential adverse events, such as pain or infection, and ensuring safe use. ^{6 7 8 9 10}

How does the MILC Application treatment for exclusive breastfeeding differ from other treatments?

The MILC Application treatment is unique because it focuses on supporting exclusive breastfeeding through a digital application, which may offer personalized guidance and support to mothers, potentially addressing challenges in establishing and maintaining exclusive breastfeeding. This approach differs from traditional methods that rely on in-person support or educational materials. ^{11 12 13 14 15}

What is the purpose of this trial?

The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF behaviors in low-income Hispanic women. Formative research conducted for the development of MILC and results from pilot testing will help guide the completion of the development and testing of this prototype that specifically caters to Hispanic women. In the long term, MILC has the potential to increase the rates of EBF and any BF up to 12 months.

Research Team

Tony Ma, MS

Principal Investigator

Benten Technologies

Yukiko Washio, PhD

Principal Investigator

RTI International

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

LATCH Score for Identification and Correction of Breastfeeding Problems - A Prospective Observational Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Improving Access to Lactation Consultation and Early Breast Milk Use in an Outborn NICU. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Australia pubmed.ncbi.nlm.nih.gov

Influence of patterns of neonatal transfers on breastfeeding outcomes. [2021]

5. Scotland pubmed.ncbi.nlm.nih.gov

Reliability and validity of the Japanese version of the Infant Breastfeeding Assessment Tool. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Breast pump adverse events: reports to the food and drug administration. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A new liquid human milk fortifier and linear growth in preterm infants. [2012]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Attitudes toward a novel breastfeeding-mediated drug and nutrient delivery system: A qualitative study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evidence-Based Updates on the First Week of Exclusive Breastfeeding Among Infants ≥35 Weeks. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of community-based drop-in centres for breastfeeding support in Victoria, Australia. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Comparison of Challenges and Problems Encountered in the Practice of Exclusive Breast Feeding by Primiparous and Multiparous Women in Rural Areas of Sindh, Pakistan: A Cross-Sectional Study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Evaluating interactive weekly mobile phone text messaging plus motivational interviewing for breastfeeding promotion among women living with HIV, giving normal birth at a primary healthcare facility in South Africa: a feasibility randomised controlled trial. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding Support in the Early Postpartum: Content of Home Visits in the SILC Trial. [2022]