Increasing Mother's Own Milk Feeding for Very Low Birth Weight Infants

(ReDiMOM Trial)

Overseen By Aloka L Patel, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Health conditions, Under 18, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

611 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is feeding very low birth weight infants with mother's own milk safe?

Feeding very low birth weight infants with mother's own milk is considered safe and provides important health benefits, such as reducing the risk of serious conditions like infections and intestinal issues. ^{1 2 3 4 5}

How does the treatment of using mother's own milk differ for very low birth weight infants?

Using mother's own milk (MOM) for very low birth weight infants is unique because it provides optimal nutrition and health benefits specifically tailored to the infant's needs, unlike formula or donor milk. It involves direct breastfeeding or expressed milk, often fortified to meet the additional nutritional needs of these infants, and requires support from healthcare providers to overcome barriers in the NICU. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Mother's Own Milk for very low birth weight infants?

Research shows that mother's own milk is the best nutrition for very low birth weight infants, providing both short- and long-term health benefits. It is especially important in the NICU setting, where it can help improve growth and reduce health issues in these vulnerable babies. ^{1 4 6 9 10}

Who Is on the Research Team?

Aloka L Patel, MD

Principal Investigator

Rush University Medical Center, Department of Pediatrics

Tricia J Johnson, PhD

Principal Investigator

Rush University Medical Center, Department of Health Systems Management

Are You a Good Fit for This Trial?

This trial is for black mothers over 18, US citizens or legal residents fluent in English/Spanish, who deliver or expect to deliver a baby under 32 weeks gestation without significant anomalies. The baby must be under 144 hours old at enrollment. Excluded are mothers with health issues preventing milk provision, those under 18, previously enrolled in this study with another pregnancy, involved in other lactation studies, or COVID-19 positive and unable to visit the NICU.

Inclusion Criteria

I am over 18, a US citizen or resident, and speak English or Spanish. My baby was or will be born before 32 weeks of pregnancy.

My baby was born before 32 weeks, is under 6 days old, and doesn't have major birth defects.

Exclusion Criteria

In the neonatologist's opinion the infant is unlikely to survive

Mother has participated in this study with a previous pregnancy

I am a mother and under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Mothers receive either standard of care lactation support or economic interventions including free hospital-grade electric breast pump, pickup of MOM, and payment for opportunity costs

10 weeks

Regular visits to NICU for MOM delivery and support

Follow-up

Participants are monitored for the volume and duration of MOM pumped and received by infants, as well as healthcare and participant costs

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mother Provides MOM
• NICU Acquires MOM

Trial Overview The trial tests if providing mother's own milk (MOM) reduces disparities in VLBW infants receiving MOM at NICU discharge compared to standard care. It will assess pumping volume/duration and economic aspects of interventions to understand implementation potential.

How Is the Trial Designed?

Group I: NICU Acquires MOM Experimental Treatment 2 Interventions

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

Group II: Mother Provides MOM Active Control 1 Intervention

Receive Rush NICU standard of care lactation support

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A quality improvement initiative in a tertiary care NICU successfully increased the use of mother's own milk (MOM) for very low birth weight infants from 55% to 88% during their hospital stay, demonstrating a 60% relative improvement.

Key strategies included education, promoting milk expression, and enhancing mother-infant interaction, which were effective in encouraging more mothers to provide their milk for enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement initiative to improve mother's own milk usage till hospital discharge in very low birth weight infants from a tertiary care NICU. Kulkarni, DV., Murki, S., Pawale, D., et al.[2021]

NICU-dedicated lactation consultants significantly increased the number of direct breastfeeding events on the day of discharge for very low birth-weight infants, indicating improved breastfeeding support.

However, there were no significant differences in overall breastfeeding outcomes or secondary measures such as days to first enteral feed or length of stay, suggesting that while direct support is beneficial, it may not impact all aspects of feeding in the NICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal Intensive Care Unit-Specific Lactation Support and Mother's Own Breast Milk Availability for Very Low Birth-Weight Infants. Mercado, K., Vittner, D., Drabant, B., et al.[2022]

Providing a mother's own milk to very low birth weight (VLBW) infants in the NICU leads to significant short- and long-term health benefits, making it the best nutritional source for these vulnerable babies.

When a mother's milk is unavailable, pasteurized human donor milk is recommended, and healthcare providers can enhance lactation support through practices like promoting skin-to-skin contact and direct breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Human Milk and Breastfeeding for the Very Low Birth Weight Infant. Parker, MG., Stellwagen, LM., Noble, L., et al.[2021]

In a study of 1,272 premature infants, early feeding with mainly mother's own milk (MOM) resulted in significantly lower weight gain compared to those receiving MOM supplemented with donor human milk (DONOR).

There were no significant differences in growth rates, length of hospital stay, or major neonatal morbidities between infants fed with MOM + DONOR and those fed with MOM + preterm formula, indicating that fortified DONOR can be a safe alternative without compromising growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Early Feeding Patterns and Neonatal Outcomes in Very Preterm Infants: A Retrospective Cohort Study. Alyahya, W., Simpson, J., Garcia, AL., et al.[2023]

The study emphasizes that measuring the volume of mother's own milk (MOM), lactation duration, and time to secretory activation are crucial for assessing lactation success in mothers of preterm infants.

Weighing expressed milk and using test weighing during breastfeeding are identified as the most reliable methods for measuring milk production, highlighting the need for consistent and valid measures to improve lactation outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures of Lactation Outcomes in Women Delivering Preterm Infants. Parker, LA., Cacho, N., Bendixen, MM., et al.[2022]

A study of 797 infants in a neonatal intensive care unit found that the likelihood of mothers stopping the provision of their own milk (MOM) increases with the number of maternal and infant risk factors present.

A Risk Calculator was developed to help healthcare teams identify mothers and infants at higher risk for discontinuing MOM, which can lead to better lactation management and improved outcomes for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Which May Contribute to the Success or Failure of the Use of Mother's Own Milk in a Level IV Neonatal Intensive Care Unit. D'Ambrosio, MA., Gabrielski, L., Melara, D., et al.[2023]

Human milk, especially a mother's own milk, significantly reduces the risk of severe health issues in hospitalized neonates, including necrotizing enterocolitis and infections, based on a review of multiple studies.

The timing and amount of human milk are crucial; earlier and larger quantities lead to better health outcomes, and when maternal milk is unavailable, donor human milk is a safer alternative to infant formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Science on the Benefits of Human Milk for Hospitalized, Vulnerable Neonates. Pados, BF.[2023]

Mother's own milk is the best nutrition for term infants and provides essential health benefits for sick and preterm infants in NICUs, but fortification is necessary for very premature infants to meet their growth and neurodevelopmental needs.

Donor milk is a valuable alternative when mother's milk is unavailable, and its use in NICUs has been shown to increase breastfeeding rates at discharge for very low birth weight infants, countering concerns that it might reduce breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of donor milk in the feeding of preterm infants. Bertino, E., Giuliani, F., Baricco, M., et al.[2013]

The study analyzed human milk from 27 mothers of very preterm infants and 34 mothers of term infants, revealing that while protein levels decreased over time in both groups, very preterm milk had higher fat and caloric content in the first two weeks, which is crucial for their nutritional needs.

Significant differences in macronutrient composition were observed at similar postmenstrual ages, with male infants showing higher fat and energy content, particularly in very preterm milk, highlighting the need for tailored fortification strategies for these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Macronutrient Composition in Preterm and Term Human Milk: A Prospective Cohort Study. Fischer Fumeaux, CJ., Garcia-Rodenas, CL., De Castro, CA., et al.[2020]

Feeding infants in the NICU with their mother's own milk (MOM) is a cost-effective way to reduce health risks associated with prematurity and improve long-term health outcomes.

To address disparities in MOM provision, it is crucial to implement strategies such as maternal education, access to lactation professionals, and support for early milk expression and breastfeeding before discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal production of milk for infants in the neonatal intensive care unit. Hoban, R., Bowker, RM., Gross, ME., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Quality improvement initiative to improve mother's own milk usage till hospital discharge in very low birth weight infants from a tertiary care NICU. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Neonatal Intensive Care Unit-Specific Lactation Support and Mother's Own Breast Milk Availability for Very Low Birth-Weight Infants. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting Human Milk and Breastfeeding for the Very Low Birth Weight Infant. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Early Feeding Patterns and Neonatal Outcomes in Very Preterm Infants: A Retrospective Cohort Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Measures of Lactation Outcomes in Women Delivering Preterm Infants. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Factors Which May Contribute to the Success or Failure of the Use of Mother's Own Milk in a Level IV Neonatal Intensive Care Unit. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

State of the Science on the Benefits of Human Milk for Hospitalized, Vulnerable Neonates. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Benefits of donor milk in the feeding of preterm infants. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Macronutrient Composition in Preterm and Term Human Milk: A Prospective Cohort Study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Maternal production of milk for infants in the neonatal intensive care unit. [2022]