Breast Pump Suction Patterns for Low Milk Supply

Overseen By Leslie A Parker, PhD, APRN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Breast surgery, Infant prognosis, Distance, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different breast pump suction patterns to determine which one helps mothers produce more milk. It targets mothers who have recently had a baby admitted to the NICU (Neonatal Intensive Care Unit) and plan to use a breast pump as their primary feeding method for the first two weeks. Participants must commit to providing only their own milk and live within 60 miles of Gainesville, FL. The trial aims to identify the most effective pumping method to help these mothers meet their feeding goals. As an unphased trial, it offers mothers the chance to contribute to important research that could improve breastfeeding support for NICU families.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with medications incompatible with providing breast milk to a NICU infant. It's best to discuss your specific medications with the trial team.

What prior data suggests that these breast pump suction patterns are safe for lactation outcomes?

Research shows that breast pump suction patterns imitating a baby's natural sucking are safe. These patterns replicate how a baby feeds during breastfeeding. Studies have found that mothers tolerate these patterns well.

For example, some breast pumps use a two-phase pattern, starting with quick, gentle suction and then switching to slower, stronger suction. This method mirrors a baby's natural feeding, ensuring safety for mothers.

No major safety concerns or negative effects have been reported with these suction patterns. Designed to resemble natural breastfeeding, they are generally considered safe for mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different breast pump suction patterns might help mothers with low milk supply. Unlike standard breast pumps that use a one-size-fits-all suction pattern, this trial investigates whether personalized suction patterns can improve milk production. By potentially offering more effective and customized pumping techniques, this trial could lead to better support for breastfeeding mothers struggling with milk supply issues.

What evidence suggests that these breast pump suction patterns are effective for improving lactation outcomes?

Research shows that breast pump suction patterns mimicking a baby's natural sucking can be more effective for mothers with low milk supply. This trial will compare different breast pump suction patterns to evaluate their effectiveness. Studies indicate that these patterns can help mothers produce more milk and initiate milk production sooner. In one study, mothers using a varied suction pattern produced significantly more milk each day. These findings suggest that the suction patterns tested in this trial can greatly enhance milk production for mothers who rely on pumping. ^{1 2 3 5 6}

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 over 18 who plan to use a breast pump exclusively for the first two weeks after giving birth, with infants in the NICU and intending to provide only their milk. It's not for those who've had breast surgery, take certain medications, live far from UFHealth, or have an infant unlikely to survive.

Inclusion Criteria

You have given birth to a baby who was admitted to the Neonatal Intensive Care Unit.

You are committed to providing your newborn with solely your own milk for the initial two weeks after delivery.

You are likely to need the aid of a breast pump for two weeks after delivery.

Exclusion Criteria

I cannot provide my own milk to my NICU infant due to my medication or health condition.

Resides over 60 miles from UFHealth

I have had breast surgery to change size.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to use one of three different breast pump suction patterns for 7 days

7 days

Daily monitoring

Follow-up

Participants are monitored for lactation outcomes and infant feeding proportions

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Breast Pump Suction Pattern

Trial Overview The study is examining how different suction patterns of breast pumps affect lactation outcomes in mothers whose newborns are critically ill and depend on pumped milk.

How Is the Trial Designed?

Group I: Breast Pump Suction Pattern 2 Active Control 1 Intervention

Group II: Breast Pump Suction Pattern 1 Active Control 1 Intervention

Group III: Breast Pump Suction Pattern 3 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Medela AG

Industry Sponsor

Trials

18

Recruited

1,800+

Published Research Related to This Trial

In a study involving 105 mothers of premature infants, newly designed breast pump suction patterns that mimic infant sucking led to significantly greater daily and cumulative milk output compared to standard methods.

The experimental initiation and standard maintenance suction patterns were found to be more effective, efficient, comfortable, and convenient for mothers during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast pump suction patterns that mimic the human infant during breastfeeding: greater milk output in less time spent pumping for breast pump-dependent mothers with premature infants. Meier, PP., Engstrom, JL., Janes, JE., et al.[2022]

Using breast pump kits from different manufacturers can significantly affect suction pressure, which is crucial for effective milk expression, as shown by tests on six pumps from Ameda, Medela, and Spectra.

Interchanging kits may lead to either inadequate suction, resulting in low milk expression, or excessive pressure, causing discomfort, highlighting the need for mothers to use manufacturer-specific kits for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interchanging Breast Pump Kit Brands Alters Breast Pump Suction Pressure. Jackson, BA., Pawlowski, CM., Weiner, GM., et al.[2021]

The study found that the current Medela electric breast pump pattern (45 cycles/min) resulted in a milk ejection time of 147 seconds, which is longer than the 56 seconds observed during breastfeeding.

While different pumping patterns that mimic infant sucking (between 45 to 125 cycles/min) did not significantly reduce the time for milk ejection, they did affect the amount of milk removed after ejection, indicating that vacuum levels can influence milk extraction efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of breasts to different stimulation patterns of an electric breast pump. Kent, JC., Ramsay, DT., Doherty, D., et al.[2017]

A study involving ten lactating mothers found that using a novel infant-derived pumping pattern did not change milk ejection characteristics or the amount of milk removed compared to a standard 2-phase pumping pattern.

Both pumping patterns resulted in similar milk volumes and ejection characteristics, reinforcing the idea that milk ejection is a consistent physiological response throughout lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maternal milk ejection characteristics during pumping using infant-derived and 2-phase vacuum patterns. Gardner, H., Kent, JC., Lai, CT., et al.[2020]

A study comparing four manual breast pumps (MBPs) found no significant differences in milk volume, nutritional composition, or breast emptying, indicating that all tested pumps are equally effective for milk expression.

Mothers preferred the squeeze-handle pumps over cylindrical ones for comfort and ease of use, highlighting the importance of user experience alongside effectiveness and cost when selecting pumps for use in special care nurseries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of four manual breast pumps for mothers after preterm delivery in a developing country. Bernabe-Garcia, M., Lopez-Alarcon, M., Villegas-Silva, R., et al.[2019]

Mothers using an irregular breast pump suction pattern (I-BPSP) produced significantly more milk daily and achieved secretory activation earlier compared to those using a standard suction pattern, based on a study of 130 mothers with infants of varying gestational ages.

The effectiveness of the I-BPSP was consistent across mothers of term, late preterm, and preterm infants, suggesting it is a beneficial approach for enhancing lactation in breast pump-dependent mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk production after preterm, late preterm and term delivery; effects of different breast pump suction patterns. Post, ED., Stam, G., Tromp, E.[2018]

A study involving 40 breastfeeding mothers in the WIC program developed a protocol for issuing single-user electric breast pumps, which may offer benefits over multi-user pumps.

The project suggests that implementing a single-user breast pump protocol could enhance support for breastfeeding mothers and improve the overall effectiveness of the WIC program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a WIC single-user electric breast pump protocol. Clark, A., Dellaport, J.[2018]

Power pumping (PP) resulted in significantly higher milk volume expressed per session compared to routine pumping (RP), with 50 mL vs. 27 mL on the 7th day, indicating that PP may enhance milk production in the short term.

Despite the increased milk volume from power pumping, there was no significant difference in exclusive breastfeeding rates at discharge between the two groups, with 61.1% in PP and 50% in RP (p=0.477), suggesting that higher milk output does not necessarily translate to improved breastfeeding outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Pumping Strategies to Improve Exclusive Breastfeeding at Discharge in Mothers of VLBW Infants with Low Milk Output - A Pilot Randomized Controlled Trial. Kalathingal, T., Manerkar, S., Mondkar, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3212618/

Breast Pump Suction Patterns that Mimic the Human Infant ... This study compared the effectiveness, efficiency, comfort and convenience of newly designed breast pump suction patterns (BPSPs) that mimic sucking of the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06061913

Comparison of Breast Pump Suction Patterns For this study, we posit that alternate breast pump suction patterns (BPSP; suction rate, intensity, and rhythm) may facilitate achievement of CTV in mothers ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21818062/

Breast pump suction patterns that mimic the human infant ... BPSPs that mimic the unique sucking patterns used by healthy-term breastfeeding infants during the initiation and maintenance of lactation are more effective, ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/13/NCT06061913/Prot_000.pdf

Comparison of Breast Pump Suction Patterns in ... The current study posits that two alternative BPSPs may be more effective in increasing pumped milk volume and thus achievement of CTV in breast ...

5. withpower.com withpower.com/trial/phase-insufficient-breast-milk-syndrome-10-2023-111d8

Breast Pump Suction Patterns for Low Milk Supply Mothers using an irregular breast pump suction pattern (I-BPSP) produced significantly more milk daily and achieved secretory activation earlier compared to ...

6. medela.com medela.com/010-products/010-pumps/040-symphony/pdf-downloads/symphony-plus-factsheet.pdf

Symphony PLUS Research-based pumping program card The MAINTAIN program is based on the. 2-Phase sucking pattern of a term born infant during established lactation. This program is designed to optimise milk ...