Improving Lactation Success in Black Mothers of Critically Ill Infants
Primary Purpose
Insufficient Lactation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hands free wearable breast pump
Sponsored by
About this trial
This is an interventional prevention trial for Insufficient Lactation
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
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Standard care group
Arm Description
Will be provided a discreet, hands-free, wearable breast pump with an associated App
Will be provided a standard mechanical breast pump with no associated App.
Outcomes
Primary Outcome Measures
Number of participants acceptance of the intervention
Survey questions regarding the number of participant acceptance of intervention
Secondary Outcome Measures
Expressed milk volume
Volume of expressed milk volume
Time to secretory activation
Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions
Expression frequency
How often mothers express daily
Lactation duration
how long mothers continue lactating
Infant consumption
percentage of feedings consisting of mother's milk consumed by infants
Full Information
NCT ID
NCT05147987
First Posted
November 8, 2021
Last Updated
December 21, 2022
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT05147987
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insufficient Lactation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Will be provided a discreet, hands-free, wearable breast pump with an associated App
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
Will be provided a standard mechanical breast pump with no associated App.
Intervention Type
Device
Intervention Name(s)
Hands free wearable breast pump
Intervention Description
Use of a supplementary breast pump which can be discreetly worn and is hands free
Primary Outcome Measure Information:
Title
Number of participants acceptance of the intervention
Description
Survey questions regarding the number of participant acceptance of intervention
Time Frame
at 20-22 days
Secondary Outcome Measure Information:
Title
Expressed milk volume
Description
Volume of expressed milk volume
Time Frame
up to 21 days
Title
Time to secretory activation
Description
Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions
Time Frame
Up to 7 days
Title
Expression frequency
Description
How often mothers express daily
Time Frame
up to 21 days
Title
Lactation duration
Description
how long mothers continue lactating
Time Frame
up to 100 days
Title
Infant consumption
Description
percentage of feedings consisting of mother's milk consumed by infants
Time Frame
up to 100 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Parker
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Parker
Phone
352-215-9360
Email
parkela@ufl.edu
First Name & Middle Initial & Last Name & Degree
Leslie Parker
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Lactation Success in Black Mothers of Critically Ill Infants
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