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Completed

NCT Number: NCT04097860

Improving Lactation Success in Mothers of Critically Infants

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

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Key information

Conditions

Breast Pumping Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Children's Hospital

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Volume of breast milk (BM)

    Time frame: 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 outcomes

  1. Number of breast pumping episodes

    Time frame: 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.

  2. Breast milk sodium level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2019
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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