Increasing Mother's Own Milk Feeding for Very Low Birth Weight Infants
(ReDiMOM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Mother's Own Milk for very low birth weight infants?
Is feeding very low birth weight infants with mother's own milk safe?
How does the treatment of using mother's own milk differ for very low birth weight infants?
Using mother's own milk (MOM) for very low birth weight infants is unique because it provides optimal nutrition and health benefits specifically tailored to the infant's needs, unlike formula or donor milk. It involves direct breastfeeding or expressed milk, often fortified to meet the additional nutritional needs of these infants, and requires support from healthcare providers to overcome barriers in the NICU.123910
What is the purpose of this trial?
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.
Research Team
Aloka L Patel, MD
Principal Investigator
Rush University Medical Center, Department of Pediatrics
Tricia J Johnson, PhD
Principal Investigator
Rush University Medical Center, Department of Health Systems Management
Eligibility Criteria
This trial is for black mothers over 18, US citizens or legal residents fluent in English/Spanish, who deliver or expect to deliver a baby under 32 weeks gestation without significant anomalies. The baby must be under 144 hours old at enrollment. Excluded are mothers with health issues preventing milk provision, those under 18, previously enrolled in this study with another pregnancy, involved in other lactation studies, or COVID-19 positive and unable to visit the NICU.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Mothers receive either standard of care lactation support or economic interventions including free hospital-grade electric breast pump, pickup of MOM, and payment for opportunity costs
Follow-up
Participants are monitored for the volume and duration of MOM pumped and received by infants, as well as healthcare and participant costs
Treatment Details
Interventions
- Mother Provides MOM
- NICU Acquires MOM
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Ohio State University
Collaborator