611 Participants Needed

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

(ReDiMOM Trial)

TJ
AL
Overseen ByAloka L Patel, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.23678

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.123910

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.

Research Team

AL

Aloka L Patel, MD

Principal Investigator

Rush University Medical Center, Department of Pediatrics

TJ

Tricia J Johnson, PhD

Principal Investigator

Rush University Medical Center, Department of Health Systems Management

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: NICU Acquires MOMExperimental Treatment2 Interventions
Receive economic interventions in addition to Rush NICU standard of care lactation support
Group II: Mother Provides MOMActive Control1 Intervention
Receive Rush NICU standard of care lactation support

Find a Clinic Near You

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+

Findings from Research

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

References

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]
Neonatal Intensive Care Unit-Specific Lactation Support and Mother's Own Breast Milk Availability for Very Low Birth-Weight Infants. [2022]
Promoting Human Milk and Breastfeeding for the Very Low Birth Weight Infant. [2021]
Association between Early Feeding Patterns and Neonatal Outcomes in Very Preterm Infants: A Retrospective Cohort Study. [2023]
Measures of Lactation Outcomes in Women Delivering Preterm Infants. [2022]
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]
State of the Science on the Benefits of Human Milk for Hospitalized, Vulnerable Neonates. [2023]
Benefits of donor milk in the feeding of preterm infants. [2013]
Longitudinal Analysis of Macronutrient Composition in Preterm and Term Human Milk: A Prospective Cohort Study. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Maternal production of milk for infants in the neonatal intensive care unit. [2022]
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