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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    611
  • sponsor
    Rush University Medical Center
Updated on 23 November 2021

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.

Description

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.

Details
Condition Very low birth weight infant, preterm delivery, premature delivery, Pumping, Breast, preterm birth, Premature, Pre-Term, human milk, Premature Birth
Treatment NICU Acquires MOM, Mother Provides MOM
Clinical Study IdentifierNCT04540575
SponsorRush University Medical Center
Last Modified on23 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

MATERNAL: 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, <96 hours of age at enrollment, multiples may be included

Exclusion Criteria

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 at time of delivery
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