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

NCT04540575 | Completed DMC

• 2 other identifiers: 18060410R01MD013969
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Race/ethnicity; Mother's Own Milk; Disparity; Economic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Receipt of any MOM

  Through study completion, an average of 10 weeks

• Duration of MOM feedings

  Through study completion, an average of 10 weeks

• Cumulative dose of MOM feedings

  Through study completion, an average of 10 weeks

• Duration of MOM pumped

  Through study completion, an average of 10 weeks

• Volume of MOM pumped

  Through study completion, an average of 10 weeks

Study Arms (2)

Mother Provides MOM

ACTIVE COMPARATOR

Receive Rush NICU standard of care lactation support

Behavioral: Mother Provides MOM

NICU Acquires MOM

EXPERIMENTAL

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

Behavioral: NICU Acquires MOM; Behavioral: Mother Provides MOM

Interventions

NICU Acquires MOM 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

NICU Acquires MOM

Mother Provides MOM BEHAVIORAL

Mother receives standard Rush NICU lactation care

Mother Provides MOM; NICU Acquires MOM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (11)

• 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.

  PMID: 24618763 BACKGROUND

• 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.

  PMID: 30679795 BACKGROUND

• 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.

  PMID: 28768286 BACKGROUND

• 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.

  PMID: 23776080 BACKGROUND

• 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.

  PMID: 28847984 BACKGROUND

• 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.

  PMID: 29490909 BACKGROUND

• 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.

  PMID: 27707877 BACKGROUND

• 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.

  PMID: 27480198 BACKGROUND

• 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.

  PMID: 29228160 BACKGROUND

• 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.

  PMID: 28167511 BACKGROUND

• 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.

  PMID: 34996401 DERIVED

MeSH Terms

Conditions

Breast Milk Expression; Premature Birth

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 7, 2020
• Study Start: December 3, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 to 5 years after publication of final results
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose and scientifically appropriate per the ReDiMOM principal investigators.

Locations

US (1)