Improving Lactation Success in Mothers of Critically Infants

Not Applicable

Active, not recruiting

• Conditions: Breast Pumping

• Registration Number: NCT04097860
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2020-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-09-03
• Study Completion: 2025-09-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volume of breast milk (BM)	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 Outcome Measures

Name	Time	Method
Breast milk sodium level	Up to 2 weeks	Daily BM sodium levels beginning when the mother has produced at least 5mL of BM and continuing for the two week study.
Number of breast pumping episodes	Up to 2 weeks	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.

Trial Locations

Locations (1)

UF Health Children's Hospital; 🇺🇸 Gainesville, Florida, United States