Insufficient Lactation
Conditions
Brief 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
DEVICEHands free wearable breast pump
Use of a supplementary breast pump which can be discreetly worn and is hands free
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Acceptance of the Intervention | at 20-22 days | Survey questions regarding the number of participant acceptance of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pumped Milk Volume | up to 21 days | Volume of Pumped milk volume |
| Days to Secretory Activation | Up to 21 days | Time from birth to a milk sodium level \< 20mMol |
| Total Pumping Sessions | up to 21 days | Total pumping sessions over 21 days |
| Lactation Duration | up to 100 days | how long mothers continue lactating |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeslie Parker
University of Florida
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 7.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
None listed