Clinical trial NCT04540575: Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
Official title: Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants: An Economic Intervention to Improve Adherence to Sustained Maternal Breast Pump Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pumping, Breast
Milk, Human
Infant, Very Low Birth Weight
Preterm Birth
Keywords: Race/ethnicity
Mother's Own Milk
Disparity
Economic
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Ohio State University
First posted: 2020-09-07
Enrollment: 611
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mothers will be randomized into one of two groups after enrollment. Group 1, or "Mother Provides Mother's Own Milk (MOM)", will receive the standard of care. Group 2, or "NICU Acquires MOM", will receive the intervention. Two levels based on gestational age (extremely preterm \< 28 weeks vs. very preterm 28-31 6/7 weeks, with approximately 50% expected in each group based on historical Rush University NICU births) will be crossed with three racial/ethnic categories (black, Hispanic, and white). The stratified random allocation table will be integrated into the baseline demographic questionnaire programmed in REDCap, allowing both patient and interviewer to be blind to condition until the end of the consent process and interview.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

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 and unable to visit the NICU due to quarantine or infection-control requirements during the 144-hour post-delivery randomization window.

Primary outcomes:
measure: Receipt of MOM at NICU Discharge
timeFrame: Through study completion, an average of 10 weeks
Secondary outcomes:
measure: Receipt of any MOM
timeFrame: Through study completion, an average of 10 weeks
measure: Duration of MOM feedings
timeFrame: Through study completion, an average of 10 weeks
measure: Cumulative dose of MOM feedings
timeFrame: Through study completion, an average of 10 weeks
measure: Duration of MOM pumped
timeFrame: Through study completion, an average of 10 weeks
measure: Volume of MOM pumped
timeFrame: Through study completion, an average of 10 weeks
measure: Healthcare system costs
timeFrame: Through study completion, an average of 10 weeks
measure: Participant costs in US Dollars
timeFrame: Through study completion, an average of 10 weeks
measure: ReDiMOM Intervention Costs in US Dollars
timeFrame: Through study completion, an average of 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center, Department of Pediatrics
name: Aloka L Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center, Department of Health Systems Management
name: Tricia J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson TJ, Patel AL, Bigger HR, Engstrom JL, Meier PP. Economic benefits and costs of human milk feedings: a strategy to reduce the risk of prematurity-related morbidities in very-low-birth-weight infants. Adv Nutr. 2014 Mar 1;5(2):207-12. doi: 10.3945/an.113.004788.
citation: Patel AL, Schoeny ME, Hoban R, Johnson TJ, Bigger H, Engstrom JL, Fleurant E, Riley B, Meier PP. Mediators of racial and ethnic disparity in mother's own milk feeding in very low birth weight infants. Pediatr Res. 2019 Apr;85(5):662-670. doi: 10.1038/s41390-019-0290-2. Epub 2019 Jan 18.
citation: Patra K, Hamilton M, Johnson TJ, Greene M, Dabrowski E, Meier PP, Patel AL. NICU Human Milk Dose and 20-Month Neurodevelopmental Outcome in Very Low Birth Weight Infants. Neonatology. 2017;112(4):330-336. doi: 10.1159/000475834. Epub 2017 Aug 3.
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citation: Johnson TJ, Meier PP, Schoeny ME, Bucek A, Janes JE, Kwiek JJ, Zupancic JAF, Keim SA, Patel AL. Study protocol for reducing disparity in receipt of mother's own milk in very low birth weight infants (ReDiMOM): a randomized trial to improve adherence to sustained maternal breast pump use. BMC Pediatr. 2022 Jan 7;22(1):27. doi: 10.1186/s12887-021-03088-y.