Improving Lactation Success in Mothers of Critically Infants

NCT04097860 | Completed

• 1 other identifier: IRB201902053
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of breast pumping episodes

  Up to 2 weeks

• Breast milk sodium level

  Up to 2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Will only be sent text messages that include the same general lactation information sent to the treatment group

Interventions

Text message including biomarker of breast pumping adequacy BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Children's Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Leslie A Parker, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals monitoring breast milk production and sodium levels will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: December 1, 2020
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: November 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)