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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: NICU Acquires MOM
* Behavioral: Mother Provides MOM


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mother Provides MOM<br>Receive Rush NICU standard of care lactation support | Behavioral: Mother Provides MOM<br>* Mother receives standard Rush NICU lactation care<br>|
| Experimental: NICU Acquires MOM<br>Receive economic interventions in addition to Rush NICU standard of care lactation support | Behavioral: NICU Acquires MOM<br>* 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<br>Behavioral: Mother Provides MOM<br>* Mother receives standard Rush NICU lactation care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of MOM at NICU Discharge | Determined from the last full day of hospitalization and categorized as Yes if the infant received any or exclusive MOM and No if the infant received only formula. | Through study completion, an average of 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of any MOM | Determined from the entire hospitalization and categorized as Yes if the infant received any or exclusive MOM and No if the never received MOM during the hospitalization. | Through study completion, an average of 10 weeks | 
| Duration of MOM feedings | Determined from the entire hospitalization and calculated as the number of days infant received any MOM. | Through study completion, an average of 10 weeks | 
| Cumulative dose of MOM feedings | Determined from the entire hospitalization and calculated as the total volume of MOM received by the infant. | Through study completion, an average of 10 weeks | 
| Duration of MOM pumped | Determined from the entire hospitalization and calculated as the number of days mother pumped MOM. | Through study completion, an average of 10 weeks | 
| Volume of MOM pumped | Determined from the entire hospitalization and calculated as the total volume of MOM pumped by the mother. | Through study completion, an average of 10 weeks | 
| Healthcare system costs | Costs borne by healthcare providers or third-party payers, including the cost of the hospital stay and donor human milk and formula costs. | Through study completion, an average of 10 weeks | 
| Participant costs in US Dollars | Participant costs will be measured in dollars and will be the sum of opportunity costs (i.e., mother's time spent pumping (mothers in control group only), time off work to visit NICU), caregiving costs for other children or adults when mother or partner visits the NICU, transportation costs, lodging costs, and other out-of-pocket costs | Through study completion, an average of 10 weeks | 
| ReDiMOM Intervention Costs in US Dollars | The costs of the intervention including milk pick-up, free provision of pumps, and opportunity costs payments for the intervention arm. | Through study completion, an average of 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Race/ethnicity, Mother's Own Milk, Disparity, Economic