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

Completed · Not applicable

Conditions studied: Pumping, Breast, Milk, Human, Infant, Very Low Birth Weight, Preterm Birth

In brief

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.

Key facts

Study ID: NCT04540575
Run by: Rush University Medical Center
People needed: 362
Starts: 2020-12-03
Expected to finish: 2025-12-31
Last updated by the study team: 2026-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.