Pumping to Up Maternal Milk Production for Preterms (PUMMPP)

Pumping to Up Maternal Milk Production for Preterms (PUMMPP)

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 Overview

• Status: Recruiting
• Conditions: Breastfeeding; Breastmilk Expression
• Intervention / Treatment: Behavioral: Pumping every 2 hours; Behavioral: breast pumping every 3 hours

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Folasade Aderibigbe, MD; Phone Number: 205-934-8793; Email: Sade.Aderibigbe72@gmail.com
• Study Contact Backup: Name: Colm Travers, MD; Phone Number: 205-934-8793; Email: cptravers@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • University of Alabama Birmingham
      • Contact: Colm Travers, MD; Phone Number: 205-934-4680; Email: cptravers@uabmc.edu
      • Contact: Folasade Aderibigbe, MD; Phone Number: 205-934-4680; Email: fmaderibigbe@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pumping every 2 hours; Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours.	Behavioral: Pumping every 2 hours; The intervention will be pumping every 2 hours.; Other Names: breast pumping every 2 hours
Active Comparator: Pumping every 3 hours; Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours.	Behavioral: breast pumping every 3 hours; The intervention will be pumping every 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of expressed breastmilk	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	From enrollment to 28 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of donor breast milk feedings	This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk.	From enrollment to 28 days of life
The number of days alive on full feedings	The total number of days the infant received full enteral feeds (≥120 milliliters(mL)/kilogram(kg)/day).	From enrollment to 28 days of life
The time to full feedings	The number of days it takes to initially reach full enteral feeds (≥120mL/kg/day)	From enrollment to 28 days of life
The number of infants with clinical evidence of feeding intolerance	Infants that have enteral feeds withheld, or in other words made "nothing by mouth" (NPO) > 24 hours for feeding or abdominal issues	From enrollment to first 28 days after birth
Number of central line days	The total number of days the infant maintained any type of central line access.	In the first 28 days of life
The number of infants receiving any volume of breastmilk at time of discharge	Infants who are still receiving any volume of expressed breastmilk upon discharge will be identified and noted.	From enrollment to hospital discharge
The number of infants exclusively feeding breastmilk at discharge	Whether or not enrolled infants are receiving all their nutrition from their mom's own expressed breastmilk upon discharge will be noted	From enrollment to hospital discharge
Average change in weight	Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age	from birth to 36 weeks' corrected gestational age
Average change in length	Changes in length measured in centimeters (cm)	from birth to 36 weeks corrected gestational age
Average change in head circumference	Change in head circumference measured in centimeters (cm)	from birth to 36 weeks' corrected gestational age
The Bayley Scales of Infant and Toddler Development (BSID)	The Bayley's cognitive component composite score will be assessed and noted. The cognitive composite score is determined by comparing the child's performance to a normative age-matched sample defined by the assessment. They are interpreted as follows: Mean score of 100 (Standard deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Monitoring is recommended, along with advice to parents on techniques to enhance development or referral to a therapist based on the level of impairment. Score below 70 (2 Standard deviation below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay.	from 18-26 months of age
The Bayley Scales of Infant and Toddler Development (BSID)	The Bayley's motor component composite score will be assessed and noted. The motor composite score is determined by comparing the child's performance to a normative age-matched sample defined by the assessment. They are interpreted as follows: Mean score of 100 (Standard deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Monitoring is recommended, along with advice to parents on techniques to enhance development or referral to a therapist based on the level of impairment. Score below 70 (2 Standard deviation below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay.	From 18-26 months of age

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• Travers CP, Carlo WA, McDonald SA, Das A, Ambalavanan N, Bell EF, Sanchez PJ, Stoll BJ, Wyckoff MH, Laptook AR, Van Meurs KP, Goldberg RN, D'Angio CT, Shankaran S, DeMauro SB, Walsh MC, Peralta-Carcelen M, Collins MV, Ball MB, Hale EC, Newman NS, Profit J, Gould JB, Lorch SA, Bann CM, Bidegain M, Higgins RD; Generic Database and Follow-up Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Racial/Ethnic Disparities Among Extremely Preterm Infants in the United States From 2002 to 2016. JAMA Netw Open. 2020 Jun 1;3(6):e206757. doi: 10.1001/jamanetworkopen.2020.6757.
• Santoli CMA, Taylor-Cho IA, Darling AJ, Montoya MN, Gilner JB, Wheeler SM, Dotters-Katz SK. Predictors of Breastfeeding among Patients Admitted with Preterm Prelabor Rupture of Membranes. Am J Perinatol. 2024 May;41(S 01):e3196-e3201. doi: 10.1055/a-2211-1787. Epub 2023 Nov 15.
• Quintero SM, Strassle PD, Londono Tobon A, Ponce S, Alhomsi A, Maldonado AI, Ko JS, Wilkerson MJ, Napoles AM. Race/ethnicity-specific associations between breastfeeding information source and breastfeeding rates among U.S. women. BMC Public Health. 2023 Mar 17;23(1):520. doi: 10.1186/s12889-023-15447-8.
• Huang Y, Liu Y, Yu XY, Zeng TY. The rates and factors of perceived insufficient milk supply: A systematic review. Matern Child Nutr. 2022 Jan;18(1):e13255. doi: 10.1111/mcn.13255. Epub 2021 Aug 12.
• Meek JY, Tippins S, American Academy of Pediatrics. American Academy of Pediatrics new mother's guide to breastfeeding. New York: Bantam Books; 2002. xiv, 258 p. p.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: breastmilk supply in preterm infant; breastfeeding preterm infants
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding; Breast Milk Expression
• Other Study ID Numbers: IRB-300013718; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No