Improving Lactation Success in Black Mothers of Critically Ill Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Insufficient Lactation

Intervention / Treatment
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* Device: Hands free wearable breast pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Will be provided a discreet, hands-free, wearable breast pump with an associated App | Device: Hands free wearable breast pump<br>* Use of a supplementary breast pump which can be discreetly worn and is hands free<br>|
| No Intervention: Standard care group<br>Will be provided a standard mechanical breast pump with no associated App. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants acceptance of the intervention | Survey questions regarding the number of participant acceptance of intervention | at 20-22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expressed milk volume | Volume of expressed milk volume | up to 21 days | 
| Time to secretory activation | Time from birth to expression of at least 20 mL of milk in 2 consecutive expressions | Up to 7 days | 
| Expression frequency | How often mothers express daily | up to 21 days | 
| Lactation duration | how long mothers continue lactating | up to 100 days | 
| Infant consumption | percentage of feedings consisting of mother's milk consumed by infants | up to 100 days |