Clinical trial NCT05147987: Improving Lactation Success in Black Mothers of Critically Ill Infants
Official title: Improving Lactation Success in Black Mothers of Critically Ill Infants in the NICU Using Discreet, Hands-free, Wearable Breast Pumps
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insufficient Lactation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants acceptance of the intervention
timeFrame: at 20-22 days
Secondary outcomes:
measure: Expressed milk volume
timeFrame: up to 21 days
measure: Time to secretory activation
timeFrame: Up to 7 days
measure: Expression frequency
timeFrame: up to 21 days
measure: Lactation duration
timeFrame: up to 100 days
measure: Infant consumption
timeFrame: up to 100 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Parker
role: PRINCIPAL_INVESTIGATOR
References: