Improving Lactation Success in Black Mothers of Critically Ill Infants

Improving Lactation Success in Black Mothers of Critically Ill Infants in the NICU Using Discreet, Hands-free, Wearable Breast Pumps

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Insufficient Lactation
• Intervention / Treatment: Device: Hands free wearable breast pump

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Will be provided a discreet, hands-free, wearable breast pump with an associated App	Device: Hands free wearable breast pump; Use of a supplementary breast pump which can be discreetly worn and is hands free
No Intervention: Standard care group; Will be provided a standard mechanical breast pump with no associated App.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants acceptance of the intervention	Survey questions regarding the number of participant acceptance of intervention	at 20-22 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expressed milk volume	Volume of expressed milk volume	up to 21 days
Time to secretory activation	Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions	Up to 7 days
Expression frequency	How often mothers express daily	up to 21 days
Lactation duration	how long mothers continue lactating	up to 100 days
Infant consumption	percentage of feedings consisting of mother's milk consumed by infants	up to 100 days

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Leslie Parker, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IRB202102029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No