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

Preterm Birth Clinical Trial

— ReDiMOM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540575
• Other study ID #: 18060410
• Secondary ID: R01MD013969
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Rush University Medical Center
• Contact: Aloka L Patel, MD
• Phone: (312) 942-6640
• Email: aloka_patel[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 611
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Infant, Very Low Birth Weight
• Milk, Human
• Premature Birth
• Preterm Birth
• Pumping, Breast

Intervention

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 $24.00/day for each day that the mother pumps during her infant's NICU stay
• Mother Provides MOM
Mother receives standard Rush NICU lactation care

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (10)

Belfort MB, Anderson PJ, Nowak VA, Lee KJ, Molesworth C, Thompson DK, Doyle LW, Inder TE. Breast Milk Feeding, Brain Development, and Neurocognitive Outcomes: A 7-Year Longitudinal Study in Infants Born at Less Than 30 Weeks' Gestation. J Pediatr. 2016 Oct;177:133-139.e1. doi: 10.1016/j.jpeds.2016.06.045. Epub 2016 Jul 29. — View Citation

Jegier BJ, Johnson TJ, Engstrom JL, Patel AL, Loera F, Meier P. The institutional cost of acquiring 100 mL of human milk for very low birth weight infants in the neonatal intensive care unit. J Hum Lact. 2013 Aug;29(3):390-9. doi: 10.1177/0890334413491629. Epub 2013 Jun 17. — View 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. — View Citation

Krubiner CB, Merritt MW. Which strings attached: ethical considerations for selecting appropriate conditionalities in conditional cash transfer programmes. J Med Ethics. 2017 Mar;43(3):167-176. doi: 10.1136/medethics-2016-103386. Epub 2016 Oct 5. — View 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. Erratum In: Pediatr Res. 2019 Sep 18;: — View 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. — View Citation

Profit J, Gould JB, Bennett M, Goldstein BA, Draper D, Phibbs CS, Lee HC. Racial/Ethnic Disparity in NICU Quality of Care Delivery. Pediatrics. 2017 Sep;140(3):e20170918. doi: 10.1542/peds.2017-0918. — View Citation

Relton C, Strong M, Thomas KJ, Whelan B, Walters SJ, Burrows J, Scott E, Viksveen P, Johnson M, Baston H, Fox-Rushby J, Anokye N, Umney D, Renfrew MJ. Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 Feb 5;172(2):e174523. doi: 10.1001/jamapediatrics.2017.4523. Epub 2018 Feb 5. — View Citation

Trang S, Zupancic JAF, Unger S, Kiss A, Bando N, Wong S, Gibbins S, O'Connor DL; GTA DoMINO Feeding Group. Cost-Effectiveness of Supplemental Donor Milk Versus Formula for Very Low Birth Weight Infants. Pediatrics. 2018 Mar;141(3):e20170737. doi: 10.1542/peds.2017-0737. — View Citation

Washio Y, Humphreys M, Colchado E, Sierra-Ortiz M, Zhang Z, Collins BN, Kilby LM, Chapman DJ, Higgins ST, Kirby KC. Incentive-based Intervention to Maintain Breastfeeding Among Low-income Puerto Rican Mothers. Pediatrics. 2017 Mar;139(3):e20163119. doi: 10.1542/peds.2016-3119. Epub 2017 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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