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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540575 on ClinicalTrials.gov