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OpenTrials
Completed

NCT Number: NCT05147987

Improving Lactation Success in Black Mothers of Critically Ill Infants

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hands free wearable breast pump

Device

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

Primary outcomes

  1. Number of participants acceptance of the intervention

    Time frame: at 20-22 days

    Survey questions regarding the number of participant acceptance of intervention

Secondary outcomes

  1. Expressed milk volume

    Time frame: up to 21 days

    Volume of expressed milk volume

  2. Time to secretory activation

    Time frame: Up to 7 days

    Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions

  3. Expression frequency

    Time frame: up to 21 days

    How often mothers express daily

  4. Lactation duration

    Time frame: up to 100 days

    how long mothers continue lactating

  5. Infant consumption

    Time frame: up to 100 days

    percentage of feedings consisting of mother's milk consumed by infants

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 7, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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