Mobile App Support for Breast Pumping Success

Overseen By Leslie A Parker, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

122 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Text message including biomarker of breast pumping adequacy?

Research shows that personalized text messages can help prolong breastfeeding among parents of critically ill infants and improve breastfeeding rates when used as part of a support program. Additionally, technology-based interventions, like smartphone apps, are preferred by many mothers for breastfeeding support, suggesting that text message interventions could be effective. ^{1 2 3 4 5}

Is the mobile app support for breast pumping safe for humans?

The research does not provide specific safety data for the mobile app support for breast pumping, but it mentions that breast pumps can cause pain, soreness, discomfort, and breast tissue damage. These issues are related to the breast pump itself, not the mobile app. ^{1 2 3 5 6}

How does the mobile app support for breast pumping differ from other treatments?

The mobile app support for breast pumping is unique because it leverages technology to provide personalized, real-time assistance and encouragement, which can enhance the breastfeeding experience. Unlike traditional methods, this app-based approach offers interactive and immediate support, potentially improving breastfeeding success rates by addressing individual needs and challenges as they arise. ^{1 5 7 8 9}

Research Team

Leslie Parker

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for mothers who plan to breastfeed their critically ill infants in the NICU and can't start bottle/breastfeeding within 14 days. They must own a mobile phone with text messaging, speak English, and be able to deliver milk to the NICU at least four times weekly. Mothers with drug use, breast surgery history, HIV, or those whose infants may not survive past one week are excluded.

Inclusion Criteria

Infant not expected to be stable enough to bottle/breastfeed for more than 14 days

You plan to breastfeed your baby.

Owns a mobile phone with unrestricted SMS capability

Exclusion Criteria

I am HIV positive.

COVID-19 positive

Known illicit drug use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive text messages to increase BM pumping frequency and production

2 weeks

Daily virtual interactions via text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Text message including biomarker of breast pumping adequacy

Trial Overview The study tests whether sending text messages that include biomarkers of adequate breast pumping can help increase the frequency of pumping and overall breast milk production for mothers of critically ill newborns.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Will be sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production

Group II: Control group Active Control 1 Intervention

Will only be sent text messages that include the same general lactation information sent to the treatment group

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

The text message-based communication platform did not significantly improve overall breastfeeding exclusivity rates at 6 weeks postpartum compared to usual care, with rates of 48.4% in the intervention group versus 41.3% in the control group.

However, among Black participants, those receiving the intervention had 2.6 times higher odds of exclusively breastfeeding compared to their counterparts in the control group, indicating a potential benefit in reducing racial disparities in breastfeeding outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message-Based Breastfeeding Support Compared With Usual Care: A Randomized Controlled Trial. Bender, W., Levine, L., Durnwald, C.[2022]

The Lactation Advice thru Texting Can Help intervention significantly improved early postpartum contact between mothers and peer counselors, with 86.6% of mothers in the texting group contacting their counselors within 48 hours of delivery compared to only 27.3% in the control group.

While exclusive breastfeeding (EBF) rates at 2 weeks postpartum were higher in the texting group (50%) compared to the control group (31.8%), the difference was not statistically significant, suggesting that the texting intervention may help mothers meet their breastfeeding goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a text message intervention used as an adjunct tool by WIC breastfeeding peer counsellors: The LATCH pilot. Harari, N., Rosenthal, MS., Bozzi, V., et al.[2020]

In a study involving low-income, first-time mothers, increased use of breastfeeding smartphone apps did not lead to higher rates of breastfeeding initiation or sustained breastfeeding compared to lower app usage, with initiation rates of 84.1% versus 78.2% respectively.

Despite the lack of impact on breastfeeding rates, both groups preferred technology-based resources for breastfeeding support, suggesting that further development of such interventions could still be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Novel Breastfeeding Smartphone Applications on Breastfeeding Rates. Griffin, LB., López, JD., Ranney, ML., et al.[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]

The MILK SMS intervention, designed to support breastfeeding, was well-received by participants, with many reporting increased confidence and perseverance in breastfeeding despite challenges, indicating its efficacy in addressing perceived insufficient milk supply.

Participants appreciated the personalized features of the MILK system and suggested improvements, such as extending support beyond 8 weeks and tailoring content to individual breastfeeding experiences, highlighting the importance of customization in digital health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial. Demirci, JR., Suffoletto, B., Doman, J., et al.[2021]

References

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

Text Message-Based Breastfeeding Support Compared With Usual Care: A Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a text message intervention used as an adjunct tool by WIC breastfeeding peer counsellors: The LATCH pilot. [2020]

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

Interventions to increase the duration of breastfeeding in obese mothers: the Bassett Improving Breastfeeding Study. [2022]

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

Effect of Novel Breastfeeding Smartphone Applications on Breastfeeding Rates. [2022]

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

Leveraging mHealth and a milk expression frequency biomarker during postpartum to prolong lactation among parents of critically ill infants: a pilot study. [2023]

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

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

7. Canada pubmed.ncbi.nlm.nih.gov

The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial. [2021]

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

The Effect of Interactive Web-Based Monitoring on Breastfeeding Exclusivity, Intensity, and Duration in Healthy, Term Infants After Hospital Discharge. [2019]

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

Randomized study comparing the efficacy of a novel manual breast pump with a mini-electric breast pump in mothers of term infants. [2018]