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NCT04540575 · ClinicalTrials.gov registry record · NA
Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 362
- Enrollment target
NCT04540575: Completed NA study, sponsored by Rush University Medical Center.
NCT04540575 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 362 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04540575, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 362 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL NICU Acquires MOM
- BEHAVIORAL Mother Provides MOM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the finished NCT04540575 record still lists
NCT04540575 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which NICU Acquires MOM is the first listed.
NCT04540575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04540575 about?
NCT04540575 is a clinical study titled "Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants". 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 signifi...
What is the current status of trial NCT04540575?
This trial is currently completed. It is a NA study. The enrollment target is 362 participants. The study started on 2020-12-03. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT04540575?
The interventions under investigation include: NICU Acquires MOM (BEHAVIORAL), Mother Provides MOM (BEHAVIORAL).
Who is sponsoring clinical trial NCT04540575?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04540575's enrollment target sits among peer trials
362 284th of 2000 higher than 1,717 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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