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?

This trial focuses on increasing the feeding of mother's own milk (MOM) for very low birth weight (VLBW) infants, particularly among black mothers who face higher risks of delivering VLBW infants and have less access to MOM feedings. The trial compares standard lactation support with additional economic interventions to determine which approach helps mothers provide more milk for a longer period. The goal is to address health disparities and improve outcomes for these infants. Mothers who have delivered or expect to deliver a baby with a gestational age of less than 32 weeks, are U.S. citizens or legal residents, and are fluent in English or Spanish may be good candidates. As an unphased trial, this study offers a unique opportunity to contribute to important research aimed at reducing health disparities and improving infant outcomes.

Will I have to stop taking my current medications?

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

What prior data suggests that this intervention is safe for very low birth weight infants?

Research has shown that giving a mother's own milk (MOM) to very low birth weight babies benefits their health. Studies have found that these feedings can lead to better health outcomes for babies both in the short and long term. The trial, "NICU Acquires MOM," helps mothers provide their own milk through financial support. This approach raises no safety concerns, as it simply increases the use of mother's milk, already known to be safe and beneficial for babies.

Using MOM is a common and safe practice in newborn care. The trial aims to make it easier for mothers to provide their milk, not to introduce new medical treatments. Therefore, the focus remains on supporting mothers, and research has reported no negative effects from these efforts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to increase the feeding of a mother's own milk (MOM) to very low birth weight infants. Unlike traditional approaches that rely solely on standard lactation support, the "NICU Acquires MOM" arm introduces economic interventions to help mothers provide more of their own milk. This experimental approach could lead to better nutritional support and improved outcomes for these vulnerable infants by addressing economic barriers that might prevent mothers from supplying their own milk. By comparing this with standard lactation support, researchers hope to uncover new strategies to enhance infant health in neonatal intensive care units.

What evidence suggests that this trial's treatments could be effective for increasing mother's own milk feeding for very low birth weight infants?

Research has shown that very low birth weight (VLBW) babies fed their mother's own milk (MOM) tend to be healthier. Studies have found that these babies have better gut and overall health compared to those not primarily fed MOM. This trial includes two approaches: the "Mother Provides MOM" arm, where mothers receive standard lactation support, and the "NICU Acquires MOM" arm, which offers economic interventions to help cover pumping costs. This can increase the chances of VLBW babies receiving MOM, potentially reducing health disparities, especially for black mothers, who are more likely to have VLBW babies. ^{2 3 6 7 8}

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

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4608232/

The Institutional Cost of Acquiring 100 mL of Human Milk ... This study aimed to determine the institutional cost of acquiring HM for VLBW infant feedings during the NICU hospitalization. Methods. This analysis examined ...

2. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-03088-y

Study protocol for reducing disparity in receipt of mother's own ... This randomized controlled trial tests the effectiveness and cost-effectiveness of an intervention to offset maternal costs associated with pumping.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9418736/

Mothers' own milk is personalized medicine for very low ... The three studies found that predominantly MOM-fed infants had better clinical outcomes, 1 , 3 healthier microbiome colonization.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04540575?tab=table

Reducing Disparity in Receipt of Mother's Own Milk in Very ... This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the ...

5. publications.aap.org publications.aap.org/pediatrics/article/148/5/e2021054272/181366/Promoting-Human-Milk-and-Breastfeeding-for-the

Promoting Human Milk and Breastfeeding for the Very Low ... Provision of mother's own milk for hospitalized very low birth weight (VLBW) (≤1500 g) infants in the NICU provides short- and long-term health benefits.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8739536/

Study protocol for reducing disparity in receipt of mother's ... This randomized control trial will enroll 284 mothers and their VP infants to test an intervention (NICU acquires MOM) developed to facilitate ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831012

Mother's Own Milk Provision During the First 12 Weeks of ... This cross-sectional study found that MOM feeding initiation and continuation rates at 12 weeks after birth for LPT infants were substantially lower than rates ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6805104/

A Quality Improvement Project to Increase Mother's Milk ... We successfully increased first milk expression ≤6 hours after birth and skin-to-skin care but did not increase mother's milk use at discharge/transfer.