Improving Lactation Success in Black Mothers of Critically Ill Infants

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05147987

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insufficient Lactation	Device: Hands free wearable breast pump	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants acceptance of the intervention [at 20-22 days]
Survey questions regarding the number of participant acceptance of intervention

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Leslie Parker, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT05147987

Other Study ID Numbers:

IRB202102029

First Posted:

Dec 7, 2021

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Jun 8, 2022