Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Volume of expressed breastmilk
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inborn infants <32 weeks gestation
- •Out-born infants transferred to our facility <48hours of life
- •Infants <1500 grams at birth
- •Infants whose parents/ guardians have provided legal consent for study participation
Exclusion Criteria
- •Infants with birthing persons' that are severe/critically ill
- •Birthing persons of infants <18 years old
- •Infants with terminal illness or decision to withhold or limit support
- •infants with major congenital anomalies, chromosomal disorders, or congenital infections
Arms & Interventions
Pumping every 2 hours
Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours.
Intervention: Pumping every 2 hours (Behavioral)
Pumping every 3 hours
Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours.
Intervention: breast pumping every 3 hours (Behavioral)
Outcomes
Primary Outcomes
Volume of expressed breastmilk
Time Frame: From enrollment to 28 days of life
The primary outcome measure will be the volume of expressed breastmilk obtained in mL per day in the group pumping every 2 hours compared the group pumping every 3 hours
Secondary Outcomes
- The percentage of donor breast milk feedings(From enrollment to 28 days of life)
- The time to full feedings(From enrollment to 28 days of life)
- The number of days alive on full feedings(From enrollment to 28 days of life)
- Average change in weight(from birth to 36 weeks' corrected gestational age)
- The number of infants with clinical evidence of feeding intolerance(From enrollment to first 28 days after birth)
- The number of infants exclusively feeding breastmilk at discharge(From enrollment to hospital discharge)
- Average change in length(from birth to 36 weeks corrected gestational age)
- Average change in head circumference(from birth to 36 weeks' corrected gestational age)
- Number of central line days(In the first 28 days of life)
- The number of infants receiving any volume of breastmilk at time of discharge(From enrollment to hospital discharge)
- The Bayley Scales of Infant and Toddler Development (BSID)(From 18-26 months of age)
- The Bayley Scales of Infant and Toddler Development (BSID)(from 18-26 months of age)
Investigators
Colm Travers
Associate Professor
University of Alabama at Birmingham