Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
NCT04540575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362
Last updated 2026-02-20
Summary
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.
Conditions
- Pumping, Breast
- Milk, Human
- Infant, Very Low Birth Weight
- Preterm Birth
Interventions
- 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
- BEHAVIORAL
-
Mother Provides MOM
Mother receives standard Rush NICU lactation care
Sponsors & Collaborators
-
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
Ohio State University
collaborator OTHER -
Rush University Medical Center
lead OTHER
Principal Investigators
-
Aloka L Patel, MD · Rush University Medical Center, Department of Pediatrics
-
Tricia J Johnson, PhD · Rush University Medical Center, Department of Health Systems Management
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-03
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- United States
Study Locations
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