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

NCT ID: NCT04540575

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Mother Provides MOM

Receive Rush NICU standard of care lactation support

Group Type: ACTIVE_COMPARATOR

Mother Provides MOM

Intervention Type: BEHAVIORAL

Mother receives standard Rush NICU lactation care

NICU Acquires MOM

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

Group Type: EXPERIMENTAL

NICU Acquires MOM

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Mother receives standard Rush NICU lactation care

Interventions

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

Intervention Type: BEHAVIORAL

Mother Provides MOM

Mother receives standard Rush NICU lactation care

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aloka L Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center, Department of Pediatrics

Tricia J Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center, Department of Health Systems Management

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aloka L Patel, MD

Role: CONTACT

aloka_patel@rush.edu

(312) 942-6033

Tricia J Johnson, PhD

Role: CONTACT

tricia_j_johnson@rush.edu

(312) 942-5402

References

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.

Reference Type: BACKGROUND

PMID: 24618763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30679795 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28768286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23776080 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28847984 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29490909 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27707877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27480198 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29228160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28167511 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34996401 (View on PubMed)

Other Identifiers

R01MD013969

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18060410

Identifier Type: -

Identifier Source: org_study_id