Improving Lactation Success in Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Pumping
- Sponsor
- University of Florida
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Volume of breast milk (BM)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Volume of breast milk (BM)
Time Frame: Up to 2 weeks
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.
Secondary Outcomes
- Breast milk sodium level(Up to 2 weeks)
- Number of breast pumping episodes(Up to 2 weeks)