Breast Pumping for Preterm Birth

(PUMMPP Trial)

Overseen By Study Faculty Advisor

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe illness, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal frequency for mothers of preterm infants to use a breast pump to increase milk supply. The goal is to determine if breast milk production varies when mothers pump every 2 hours versus every 3 hours. Participants will record their milk output daily for the first 28 days of their baby's life. Mothers with preterm babies born at less than 32 weeks or weighing under 1500 grams may be suitable for this study. As an unphased trial, this study provides mothers the opportunity to contribute to important research that could enhance care for preterm infants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this breast-pumping protocol is safe for mothers of preterm infants?

Research shows that breast pumping is generally safe for mothers of premature babies. Hospitals often suggest pumping every 2-3 hours to help mothers produce more milk. Studies have found that pumping is common for mothers with early-born babies because it can increase milk supply, which is important for the baby's nutrition.

Specific data does not show safety issues with pumping every 2 hours compared to every 3 hours. However, using a breast pump is a well-known way to express milk, and serious problems are rare. This trial examines how different pumping schedules affect milk quantity, not safety concerns.

Overall, breast pumps are considered safe and are widely used by mothers in similar situations. Prospective participants can feel confident that pumping is a standard, safe practice. This study simply explores the best schedule to help increase milk production. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different breast pumping schedules to boost milk production for mothers of preterm infants. Unlike standard practices that might not have a set pumping frequency, this study examines the effects of pumping every 2 hours versus every 3 hours. The potential for increased milk supply with more frequent pumping could offer critical benefits for the nutrition and immunity of preterm babies, providing them with the vital nutrients they need to thrive. By identifying an optimal pumping schedule, this trial could help improve outcomes for both mothers and their newborns.

What evidence suggests that this pumping method is effective for increasing breast milk supply in mothers of preterm infants?

Research has shown that more frequent breast milk pumping can help mothers of premature babies produce more milk. In this trial, participants will follow different pumping schedules. Studies have found that pumping every 2 hours, one of the schedules tested in this trial, often results in more milk than less frequent pumping. Frequent pumping mimics a baby's natural feeding pattern, which encourages milk production. The trial aims to increase milk supply by regularly stimulating the breasts. While results can vary for each person, more frequent pumping generally leads to better milk production for mothers with preterm infants.

Are You a Good Fit for This Trial?

This trial is for mothers with preterm infants born before 32 weeks gestation or weighing less than 1500 grams at birth. It's also open to those transferred to the facility within 48 hours of life. Participants must have legal consent from parents or guardians.

Inclusion Criteria

My child is enrolled with my consent.

My baby was born before 32 weeks of pregnancy.

My baby was transferred to this facility within 48 hours of being born elsewhere.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to pump every 2 or 3 hours and record breastmilk volume for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pumping to Up Maternal Milk Production

Trial Overview The study compares the effects of breast pumping frequency on milk supply in mothers of preterm babies. One group will pump every two hours, while another will do so every three hours, measuring daily milk production for the first four weeks.

How Is the Trial Designed?

Group I: Pumping every 2 hours Experimental Treatment 1 Intervention

Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours.

Group II: Pumping every 3 hours Active Control 1 Intervention

Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. withpower.com withpower.com/trial/phase-premature-birth-11-2025-265aa

Breast Pumping for Preterm Birth (PUMMPP Trial) The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5328421/

Evidence-based methods that promote human milk feeding of ... However, many breast pump-dependent mothers of preterm infants have chronic health problems or pregnancy and birth complications that impact lactation outcomes ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457723022416

Principles of feeding the preterm infant Human milk is preferred in preterm infants for its protective effects against necrotising enterocolitis, inflammation, and neurodevelopmental delay.

4. journals.lww.com journals.lww.com/jncqjournal/fulltext/9900/early_milk_expression_for_mothers_of_premature.243.aspx

Early Milk Expression for Mothers of Premature Infants and... Mothers are instructed by nurses and lactation consultants to pump every 2-3 hours and at least 8 times a day. They are given a paper milk log in their welcome ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/08903344231211513

A Nursing-Driven Program to Support Human Milk Feeding ... Breastfeeding is strongly recommended in all preterm infants to promote improved outcomes (World Health Organization, 2022). However, any and ...