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NCT05147987 · ClinicalTrials.gov registry record · NA
Improving Lactation Success in Black Mothers of Critically Ill Infants
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05147987: Completed NA study, sponsored by University of Florida.
NCT05147987 is a NA study that has completed, run by University of Florida. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147987, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadequate daily breast pumping frequency. Black mothers face unique challenges to frequent breast pumping including returning to work earlier, working in facilities with inadequate lactation support, and limited privacy for breast pumping at home. Therefore, the objective of this pilot study is to determine the feasibility and potential benefits of using a discreet, hands-free, wearable breast pump with an associated App that tracks pumping frequency and BM production to increase lactation success in Black mothers of infants admitted to the NICU. Specific aims include (1) evaluate the feasibility of a discreet, hands-free, wearable pump in Black mothers of critically ill infants to increase pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 40 Black mothers of critically ill infants will be randomized to one of two groups. Group 1 will be provided a discreet, hands-free, wearable breast pump with an associated App and Group 2 will be provided a standard mechanical breast pump with no associated App. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.
Primary Outcome
Survey questions regarding the number of participant acceptance of intervention
Interventions
- DEVICE Hands free wearable breast pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2025-02-15 |
| Phase | NA |
What the finished NCT05147987 record still lists
NCT05147987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Hands free wearable breast pump is the first listed.
NCT05147987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05147987 about?
NCT05147987 is a clinical study titled "Improving Lactation Success in Black Mothers of Critically Ill Infants". Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadeq...
What is the current status of trial NCT05147987?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-01-01. Estimated completion is 2025-02-15.
What interventions are being tested in trial NCT05147987?
The interventions under investigation include: Hands free wearable breast pump (DEVICE).
Who is sponsoring clinical trial NCT05147987?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05147987's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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