Improving Lactation Success in Black Mothers of Critically Ill Infants

  • STATUS
    Recruiting
  • days left to enroll
    38
  • participants needed
    40
  • sponsor
    University of Florida
Updated on 16 June 2022
Accepts healthy volunteers

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.

Details
Condition Insufficient Lactation
Treatment Hands free wearable breast pump
Clinical Study IdentifierNCT05147987
SponsorUniversity of Florida
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Mothers self-identified as Black
> 18 years of age
English speaking
Stated intent to provide breast milk to her infant
Rate their level of commitment to pumping breast milk for their infant for at least 3 weeks as 3 or greater or a 1-5 point Likert scale
State they are available for an approximately 30 minute education session prior to hospital discharge
Infant not expected to be stable enough to bottle/breastfeed for > 21 days
Access to a mobile phone and able to download app

Exclusion Criteria

Known illicit drug use
Breast reduction or augmentation
Positive HIV status
Infant not expected to live > 7 days following delivery
Has pacemaker
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