University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT05147987
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Gainesville, Florida, 32610, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a supplementary breast pump which can be discreetly worn and is hands free
Time frame: at 20-22 days
Survey questions regarding the number of participant acceptance of intervention
Time frame: up to 21 days
Volume of expressed milk volume
Time frame: Up to 7 days
Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions
Time frame: up to 21 days
How often mothers express daily
Time frame: up to 100 days
how long mothers continue lactating
Time frame: up to 100 days
percentage of feedings consisting of mother's milk consumed by infants
University of Florida
Other
Improving Lactation Success in Black Mothers of Critically Ill Infants in the NICU Using Discreet, Hands-free, Wearable Breast Pumps
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