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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 is a NA study that has completed, run by University of Florida. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05147987
The ClinicalTrials.gov registry entry for NCT05147987 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hands free wearable breast pump is the first listed.
NCT05147987 reports 0 study locations.
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.
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