Improving Lactation Success in Black Mothers of Critically Ill Infants

NCT ID: NCT05147987

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-10-01

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.

Conditions

Insufficient Lactation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Will be provided a discreet, hands-free, wearable breast pump with an associated App

Group Type: EXPERIMENTAL

Hands free wearable breast pump

Intervention Type: DEVICE

Use of a supplementary breast pump which can be discreetly worn and is hands free

Standard care group

Will be provided a standard mechanical breast pump with no associated App.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hands free wearable breast pump

Use of a supplementary breast pump which can be discreetly worn and is hands free

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Parker

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202102029

Identifier Type: -

Identifier Source: org_study_id