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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05147987
Other study ID # IRB202102029
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03574766 - Meditation for NICU Moms N/A
Completed NCT03806062 - EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION Phase 4