Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants (ReDiMOM)

February 18, 2026 updated by: Rush University Medical Center

Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants: An Economic Intervention to Improve Adherence to Sustained Maternal Breast Pump Use

In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs.

This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Even though black mothers of VLBW infants initiate MOM provision at rates similar to nonblack mothers and have similar goals to sustain MOM provision through to NICU discharge, there is a significant disparity in MOM feedings at NICU discharge. Only the mother can mitigate the disparity in MOM feedings at NICU discharge for the VLBW infant by: 1) sustaining breast pump use (6-8 times/day) for the entire NICU hospitalization (average = 73 days), and 2) transporting the MOM that is pumped in the home to the NICU for infant feedings. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs.

The ReDiMOM randomized controlled trial will implement and evaluate an intervention (NICU acquires MOM) developed to offset the aforementioned costs that serve as barriers to sustaining MOM feedings. The intervention includes free hospital-grade electric breast pump, pickup of MOM, and payment for opportunity costs. The intervention will be evaluated in comparison to the current standard of care (mother provides MOM). Data will be collected from several sources including REDCap surveys, data extraction from the electronic medical record and hospital decision support/financial cost accounting system, smart breast pump data and measurement of pumped MOM volume.

This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • MATERNAL: Delivery, or anticipated delivery, of infant with gestational age < 32 0/7 weeks at Rush, age ≥18 years, US citizen or legal resident, fluent in English or Spanish
  • INFANT: Birth gestational age (GA)< 32 0/7 weeks, no significant congenital anomalies or chromosomal defects, <144 hours of age at enrollment, multiples may be included

Exclusion Criteria:

  • Mothers with health conditions that are incompatible with milk provision per the clinical judgment of the NICU attending caring for the infant, mother is less than 18 years of age, mother has participated in this study with a previous pregnancy, mother is enrolled in another study that impacts lactation, in the neonatologist's opinion the infant is unlikely to survive, or mother is coronavirus (COVID-19) positive and unable to visit the NICU due to quarantine or infection-control requirements during the 144-hour post-delivery randomization window.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mother Provides MOM
Receive Rush NICU standard of care lactation support
Behavioral: Mother Provides MOM
Mother receives standard Rush NICU lactation care
Experimental: NICU Acquires MOM
Receive economic interventions in addition to Rush NICU standard of care lactation support
Behavioral: Mother Provides MOM
Mother receives standard Rush NICU lactation care
Behavioral: NICU Acquires MOM
Mother receives 1) hospital-grade electric smart breast pump for home use at no charge to the mother while the infant is in the NICU and the mother continues to pump; 2) free pickup of expressed MOM from home to transport to NICU 2-3 times per week during weekdays as needed; 3) receives payment for opportunity costs of pumping and handling milk at $24.00/day for each day that the mother pumps during her infant's NICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of MOM at NICU Discharge
Time Frame: Through study completion, an average of 10 weeks
Determined from the last full day of hospitalization and categorized as "Yes" if the infant received any or exclusive MOM and "No" if the infant received only formula.
Through study completion, an average of 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of any MOM
Time Frame: Through study completion, an average of 10 weeks
Determined from the entire hospitalization and categorized as "Yes" if the infant received any or exclusive MOM and "No" if the never received MOM during the hospitalization.
Through study completion, an average of 10 weeks
Duration of MOM feedings
Time Frame: Through study completion, an average of 10 weeks
Determined from the entire hospitalization and calculated as the number of days infant received any MOM.
Through study completion, an average of 10 weeks
Cumulative dose of MOM feedings
Time Frame: Through study completion, an average of 10 weeks
Determined from the entire hospitalization and calculated as the total volume of MOM received by the infant.
Through study completion, an average of 10 weeks
Duration of MOM pumped
Time Frame: Through study completion, an average of 10 weeks
Determined from the entire hospitalization and calculated as the number of days mother pumped MOM.
Through study completion, an average of 10 weeks
Volume of MOM pumped
Time Frame: Through study completion, an average of 10 weeks
Determined from the entire hospitalization and calculated as the total volume of MOM pumped by the mother.
Through study completion, an average of 10 weeks
Healthcare system costs
Time Frame: Through study completion, an average of 10 weeks
Costs borne by healthcare providers or third-party payers, including the cost of the hospital stay and donor human milk and formula costs.
Through study completion, an average of 10 weeks
Participant costs in US Dollars
Time Frame: Through study completion, an average of 10 weeks
Participant costs will be measured in dollars and will be the sum of opportunity costs (i.e., mother's time spent pumping (mothers in control group only), time off work to visit NICU), caregiving costs for other children or adults when mother or partner visits the NICU, transportation costs, lodging costs, and other out-of-pocket costs
Through study completion, an average of 10 weeks
ReDiMOM Intervention Costs in US Dollars
Time Frame: Through study completion, an average of 10 weeks
The costs of the intervention including milk pick-up, free provision of pumps, and opportunity costs payments for the intervention arm.
Through study completion, an average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Ohio State University

Investigators

  • Principal Investigator: Aloka L Patel, MD, Rush University Medical Center, Department of Pediatrics
  • Principal Investigator: Tricia J Johnson, PhD, Rush University Medical Center, Department of Health Systems Management

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18060410
  • R01MD013969 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification

IPD Sharing Time Frame

2 to 5 years after publication of final results

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose and scientifically appropriate per the ReDiMOM principal investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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