Clinical trial NCT04097860: Improving Lactation Success in Mothers of Critically Infants
Official title: Improving Lactation Success in Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Pumping
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Volume of breast milk (BM)
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Number of breast pumping episodes
timeFrame: Up to 2 weeks
measure: Breast milk sodium level
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Children's Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie A Parker, MD
role: PRINCIPAL_INVESTIGATOR
References: