Improving Lactation Success in Mothers of Critically Infants

Improving Lactation Success in Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Pumping
• Intervention / Treatment: Behavioral: Text message including biomarker of breast pumping adequacy

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie A Parker, MD; Phone Number: 352 215 9360; Email: parkela@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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; 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
No Intervention: Control group; Will only be sent text messages that include the same general lactation information sent to the treatment group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Leslie A Parker, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): September 3, 2025
• Study Completion (Estimated): September 3, 2025

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB201902053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No