Sodium Awareness in Lactation Trial (SALT)

Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers

SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population.

Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum

Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes

Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Breastfeeding; Breast Pumping; Lactation; Insufficient, Partial
• Intervention / Treatment: Diagnostic test: point-of-care milk sodium testing

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha J. Anthony, PhD; Phone Number: 303126 (416) 813-7654; Email: samantha.anthony@sickkids.ca
• Study Contact Backup: Name: Rebecca Hobban, MD, MPH; Email: Rebecca.Hoban@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Debbie Ng, MPH; Email: ngdm@uw.edu
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center - Montlake
      • Contact: Debbie Ng, MPH; Email: ngdm@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Consent provided
2. Have delivered a preterm singleton or twin infant at <35 weeks gestation admitted to a study NICU at birth or transferred into a study NICU from another NICU within the first 72 hours postpartum
3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump
5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)

Exclusion Criteria:

1. Potential study participant's infant is critically ill and not expected to survive or has lethal diagnosis with plans by medical team/family to redirect care
2. Has delivered triplets or higher order multiples (potential confounder for lactation challenges; of note, triplets or higher are rare, on the order of a few parents annually)
3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
6. Unable/unwilling to be present in study NICU during any of first 5 days postpartum
7. Presumption by the medical team that infant will be in study NICU for <5 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic	We will collect time cost of milk testing, including teaching parents how to test milk and daily time testing milk. This outcome will include time (in hours) spent in the first 14 days for parent and staff, with a health economist determining costs for that time	First 14 days postpartum
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews	We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews	First 14 days postpartum
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys	We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys	First 14 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).	We will assess interrelationships between aforementioned factors and milk provision at NICU discharge (exclusive, any, none). Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcome cannot be separated.	Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)
Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)	We will assess interrelationships between aforementioned factors and coming to volume (pumping at least 500mL/day by postpartum day 14).Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcomes cannot be separated.	First 14 days postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore if POC Na data used to recommend changes in pumping behaviour is associated with actual changes in parent pumping behaviour	Explore in parents whom we recommend to modify pumping frequency, rates of coming to volume by day 14 (pumping at least 500mL/day)	First 14 days postpartum
Explore how POC Na data used to recommend changes in pumping behaviour is associated with short-term milk volumes	Determine in parents whom we recommend to modify pumping frequency based on POC Na, how often they actually followed our recommendations	First 14 days postpartum

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: University of Washington
• Investigators: Principal Investigator: Samantha J. Anthony, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: PJM-185757

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