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Search / Trial NCT04540575

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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Aug 31, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Race/Ethnicity Mother's Own Milk Disparity Economic

ClinConnect Summary

This clinical trial is focused on improving the chances that very low birth weight infants—those born weighing less than 3.3 pounds—receive their mother's own milk while they are in the neonatal intensive care unit (NICU). Research shows that black mothers are less likely to provide their own milk for these infants, which can lead to more health problems and higher medical costs later in life. The trial aims to test an intervention that helps mothers pump more milk and continue doing so for a longer time. By doing this, the hope is that more infants will receive their mother's milk when they leave the NICU.

To participate in this trial, mothers must be at least 18 years old, fluent in English or Spanish, and have given birth or are about to give birth to a baby under 32 weeks of gestational age. The babies must also meet specific health criteria. Participants can expect support and resources to help with milk pumping, and their progress will be compared to mothers who receive standard care. This research is essential because it could lead to better support for moms and healthier outcomes for their babies.

Gender

ALL

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.

About Rush University Medical Center

Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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