Improving Lactation Success in Black Mothers of Critically Ill Infants

NCT05147987 | Completed FDA Device

• 1 other identifier: IRB202102029
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants acceptance of the intervention

  Survey questions regarding the number of participant acceptance of intervention

  at 20-22 days

Secondary Outcomes (5)

• Expressed milk volume

  up to 21 days

• Time to secretory activation

  Up to 7 days

• Expression frequency

  up to 21 days

• Lactation duration

  up to 100 days

• Infant consumption

  up to 100 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: Hands free wearable breast pump

Standard care group

NO INTERVENTION

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

Interventions

Hands free wearable breast pump DEVICE

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known illicit drug use
• Breast reduction or augmentation
• Positive HIV status
• Infant not expected to live \> 7 days following delivery
• Has pacemaker

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Lactation Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leslie Parker

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 7, 2021
• Study Start: January 1, 2022
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: February 3, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)