Improving Lactation Success in Black Mothers of Critically Ill Infants

Insufficient Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05147987
• Other study ID #: IRB202102029
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Insufficient Lactation

Intervention

Device:
• Hands free wearable breast pump
Use of a supplementary breast pump which can be discreetly worn and is hands free

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants acceptance of the intervention	Survey questions regarding the number of participant acceptance of intervention	at 20-22 days
Secondary	Expressed milk volume	Volume of expressed milk volume	up to 21 days
Secondary	Time to secretory activation	Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions	Up to 7 days
Secondary	Expression frequency	How often mothers express daily	up to 21 days
Secondary	Lactation duration	how long mothers continue lactating	up to 100 days
Secondary	Infant consumption	percentage of feedings consisting of mother's milk consumed by infants	up to 100 days