Pumping to Up Maternal Milk Production for Preterms

NCT06673160 | Recruiting DMC

• 2 other identifiers: IRB-300013718UAB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Breastmilk Expression

Keywords

breastmilk supply in preterm infant; breastfeeding preterm infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• The percentage of donor breast milk feedings

  From enrollment to 28 days of life

• The number of days alive on full feedings

  From enrollment to 28 days of life

• The time to full feedings

  From enrollment to 28 days of life

• The number of infants with clinical evidence of feeding intolerance

  From enrollment to first 28 days after birth

• Number of central line days

  In the first 28 days of life

Study Arms (2)

Pumping every 2 hours

EXPERIMENTAL

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

Behavioral: Pumping every 2 hours

Pumping every 3 hours

ACTIVE COMPARATOR

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

Behavioral: breast pumping every 3 hours

Interventions

Pumping every 2 hours BEHAVIORAL

The intervention will be pumping every 2 hours.

Also known as: breast pumping every 2 hours

Pumping every 2 hours

breast pumping every 3 hours BEHAVIORAL

The intervention will be pumping every 3 hours

Pumping every 3 hours

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 32520359 BACKGROUND

• 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.

  PMID: 37967869 BACKGROUND

• 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.

  PMID: 36932332 BACKGROUND

• 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.

  PMID: 34382733 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Colm Travers, MD

CONTACT

205-934-8793; cptravers@uabmc.edu

Folasade Aderibigbe, MD

CONTACT

205-934-8793; Sade.Aderibigbe72@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 4, 2024
• Study Start: June 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)