An interventional study of NICU Acquires MOM and Mother Provides MOM in Pumping, Breast, Milk, Human and Infant, Very Low Birth Weight, sponsored by Rush University Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Health services research
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.
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.
Exclusion Criteria:
Receive Rush NICU standard of care lactation support
Behavioral: Mother Provides MOM
Receive economic interventions in addition to Rush NICU standard of care lactation support
Behavioral: NICU Acquires MOM · Behavioral: Mother Provides 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
Mother receives standard Rush NICU lactation care
Receipt of MOM at NICU Discharge
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.
Time frame: Through study completion, an average of 10 weeks
Receipt of any MOM
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.
Time frame: Through study completion, an average of 10 weeks
Duration of MOM feedings
Determined from the entire hospitalization and calculated as the number of days infant received any MOM.
Time frame: Through study completion, an average of 10 weeks
Cumulative dose of MOM feedings
Determined from the entire hospitalization and calculated as the total volume of MOM received by the infant.
Time frame: Through study completion, an average of 10 weeks
Duration of MOM pumped
Determined from the entire hospitalization and calculated as the number of days mother pumped MOM.
Time frame: Through study completion, an average of 10 weeks
Volume of MOM pumped
Determined from the entire hospitalization and calculated as the total volume of MOM pumped by the mother.
Time frame: Through study completion, an average of 10 weeks
Healthcare system costs
Costs borne by healthcare providers or third-party payers, including the cost of the hospital stay and donor human milk and formula costs.
Time frame: Through study completion, an average of 10 weeks
Participant costs in US Dollars
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
Time frame: Through study completion, an average of 10 weeks
ReDiMOM Intervention Costs in US Dollars
The costs of the intervention including milk pick-up, free provision of pumps, and opportunity costs payments for the intervention arm.
Time frame: Through study completion, an average of 10 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification
Supporting information: Study protocol, Icf
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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