Improving Lactation Success in Mothers of Critically Infants

Breast Pumping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04097860
• Other study ID #: IRB201902053
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 3, 2025

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: September 3, 2025
• Est. primary completion date: September 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Pumping

Intervention

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

Locations

Country	Name	City	State
United States	UF Health Children's Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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