Improving Lactation Success in Mothers of Critically Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit

Detailed Description
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Although compelling evidence exists that breast milk (BM) improves infant health, mothers of critically ill infants frequently produce insufficient amounts BM which is likely due to inadequate daily breast pumping frequency. BM sodium levels are an easy to measure biomarker of pumping frequency and providing this information to mothers via text messaging may increase their pumping frequency and BM production. Therefore, the overall objective of this pilot study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit (NICU) at University of Florida Health. Specific aims include (1) evaluate the feasibility of a mHealth intervention to increase BM 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, 50 mothers of critically ill infants admitted to the NICU will be randomized to one of two groups. The Enhanced Intervention Group will receive text messages including both general lactation information and a personalized message consisting of the mother's BM sodium level, pumping frequency and feedback regarding pumping frequency. The Standard Intervention Group will receive only general lactation information. 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 Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages

Conditions
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Breast Pumping

Intervention / Treatment
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* Behavioral: Text message including biomarker of breast pumping adequacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stated intent to provide BM to the infant infant not expected to be stable enough to bottle/breastfeed for > 14 days owns a mobile phone with unrestricted SMS capability. English speaking Exclusion Criteria: known illicit drug use breast reduction or augmentation positive HIV status does not anticipate being able to bring BM to the NICU at least 4X/week infant not expected to live > 7 days following delivery COVID-19 positive

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 sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production | Behavioral: Text message including biomarker of breast pumping adequacy<br>* The intervention group will be sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the participant is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production<br>|
| No Intervention: Control group<br>Will only be sent text messages that include the same general lactation information sent to the treatment group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of breast milk (BM) | All BM will be weighed (1 mg of BM = 1 mL) by a BM technician and the weight recorded in the infant's medical record. BM will be weighed on a portable digital scale accurate to within 0.1 grams. | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of breast pumping episodes | Daily number of pumping sessions as recorded in the mother's log book and verified by examination of the date and time on vials of pumped BM. | Up to 2 weeks | 
| Breast milk sodium level | Daily BM sodium levels beginning when the mother has produced at least 5mL of BM and continuing for the two week study. | Up to 2 weeks |