Pumping to Up Maternal Milk Production for Preterms

NCT ID: NCT06673160

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breastfeeding Breastmilk Expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pumping every 2 hours

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

Group Type EXPERIMENTAL

Pumping every 2 hours

Intervention Type BEHAVIORAL

The intervention will be pumping every 2 hours.

Pumping every 3 hours

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

Group Type ACTIVE_COMPARATOR

breast pumping every 3 hours

Intervention Type BEHAVIORAL

The intervention will be pumping every 3 hours

Interventions

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Pumping every 2 hours

The intervention will be pumping every 2 hours.

Intervention Type BEHAVIORAL

breast pumping every 3 hours

The intervention will be pumping every 3 hours

Intervention Type BEHAVIORAL

Other Intervention Names

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breast pumping every 2 hours

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Folasade Aderibigbe

Fellow Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Folasade Aderibigbe, MD

Role: CONTACT

205-934-8793

Study Faculty Advisor

Role: CONTACT

Facility Contacts

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Folasade Aderibigbe, MD

Role: primary

205-934-4680

Colm Travers, MD

Role: backup

205-934-4680

References

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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.

Reference Type BACKGROUND
PMID: 32520359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37967869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36932332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34382733 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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IRB-300013718

Identifier Type: -

Identifier Source: org_study_id

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