Mobile App Support for Breast Pumping Success

Overseen By Leslie A Parker, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Illicit drug use, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a mobile app can assist mothers who pump breast milk for critically ill babies in the NICU. The app sends text messages with general tips and personalized feedback based on breast milk sodium levels, which indicate breast pumping adequacy. The goal is to determine if this encourages mothers to pump more frequently and produce more milk. Mothers with critically ill babies not ready to breastfeed for two weeks, who plan to provide breast milk, and have a phone capable of receiving texts might be suitable candidates. As an unphased trial, this study offers a unique opportunity for mothers to contribute to research that could enhance breastfeeding support in the NICU.

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 prior data suggests that this mHealth intervention is safe for increasing breast milk production?

Research has shown that sending text messages can safely and effectively support breastfeeding mothers. In various studies, mothers who received text messages about breastfeeding felt more confident and supported than those who did not.

One study found that sending text messages to mothers during pregnancy and after birth increased breastfeeding rates. These weekly messages encouraged exclusive breastfeeding, meaning the baby received only breast milk without other foods or drinks.

Overall, using text messages to support breastfeeding has been well-received and appears harmless. Mothers generally find these messages helpful for boosting confidence and receiving necessary support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to supporting breastfeeding mothers using personalized text messages. Unlike standard breastfeeding advice, which often provides general tips, this method includes real-time data by sending mothers information about the sodium levels in their breast milk. This personalized feedback can help mothers understand their pumping effectiveness and adjust their routines to optimize breast milk production. By offering tailored guidance, this approach aims to empower mothers with actionable insights, potentially enhancing their breastfeeding success.

What evidence suggests that this mobile app support is effective for increasing breast milk production?

This trial will compare the effects of personalized text messages with general lactation information on breastfeeding success. Studies have shown that personalized text messages based on biological indicators can support breastfeeding in mothers with very sick babies. Research indicates that these messages may encourage more frequent breast milk pumping and improve milk production. Specifically, one study found that when mothers received messages about the salt levels in their breast milk, along with advice on pumping, they adjusted their habits to produce more milk. This personalized feedback can be a helpful tool for mothers trying to continue breastfeeding under challenging conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Leslie Parker

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

COVID-19 positive

I am HIV positive.

Known illicit drug use

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

Citations

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Conclusion: Personalized biomarker-based text messages are feasible and may support lactation in mothers of critically ill infants.

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

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Usability and Usefulness of SMS-Based Artificial Intelligence ...

This study evaluates the effectiveness of Mwana, an AI-powered SMS-based app, in improving breastfeeding outcomes for postpartum mothers in Lagos, Nigeria.