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?

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. The main question it aims to answer is: - What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.

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+