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

Sponsor

Rush University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04540575

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH), Ohio State University (Other)

611

Enrollment

Location

Arms

48.9

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pumping, Breast Milk, Human Infant, Very Low Birth Weight Preterm Birth	Behavioral: NICU Acquires MOM Behavioral: Mother Provides MOM	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

611 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Dec 3, 2020

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mother Provides MOM Receive Rush NICU standard of care lactation support	Behavioral: Mother Provides MOM Mother receives standard Rush NICU lactation care
Experimental: NICU Acquires MOM Receive economic interventions in addition to Rush NICU standard of care lactation support	Behavioral: NICU Acquires MOM 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 $18.50/day for each day that the mother pumps during her infant's NICU stay Behavioral: Mother Provides MOM Mother receives standard Rush NICU lactation care

Arm

Intervention/Treatment

Active Comparator: Mother Provides MOM

Receive Rush NICU standard of care lactation support

Behavioral: Mother Provides MOM

Mother receives standard Rush NICU lactation care

Experimental: NICU Acquires MOM

Receive economic interventions in addition to Rush NICU standard of care lactation support

Behavioral: NICU Acquires MOM

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 $18.50/day for each day that the mother pumps during her infant's NICU stay

Behavioral: Mother Provides MOM

Mother receives standard Rush NICU lactation care

Outcome Measures

Primary Outcome Measures

Receipt of MOM at NICU Discharge [Through study completion, an average of 10 weeks]
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.

Secondary Outcome Measures

Receipt of any MOM [Through study completion, an average of 10 weeks]
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.
Duration of MOM feedings [Through study completion, an average of 10 weeks]
Determined from the entire hospitalization and calculated as the number of days infant received any MOM.
Cumulative dose of MOM feedings [Through study completion, an average of 10 weeks]
Determined from the entire hospitalization and calculated as the total volume of MOM received by the infant.
Duration of MOM pumped [Through study completion, an average of 10 weeks]
Determined from the entire hospitalization and calculated as the number of days mother pumped MOM.
Volume of MOM pumped [Through study completion, an average of 10 weeks]
Determined from the entire hospitalization and calculated as the total volume of MOM pumped by the mother.
Healthcare system costs [Through study completion, an average of 10 weeks]
Costs borne by healthcare providers or third-party payers, including the cost of the hospital stay and donor human milk and formula costs.
Participant costs in US Dollars [Through study completion, an average of 10 weeks]
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
ReDiMOM Intervention Costs in US Dollars [Through study completion, an average of 10 weeks]
The costs of the intervention including milk pick-up, free provision of pumps, and opportunity costs payments for the intervention arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center
National Institute on Minority Health and Health Disparities (NIMHD)
Ohio State University

Investigators

Principal Investigator: Aloka L Patel, MD, Rush University Medical Center, Department of Pediatrics
Principal Investigator: Tricia J Johnson, PhD, Rush University Medical Center, Department of Health Systems Management