Actively Recruiting
Sodium Awareness in Lactation Trial
Led by The Hospital for Sick Children · Updated on 2025-05-28
40
Participants Needed
2
Research Sites
50 weeks
Total Duration
On this page
Sponsors
T
The Hospital for Sick Children
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Sodium Awareness in Lactation Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent provided
- Delivered a preterm singleton or twin infant before 35 weeks gestation admitted to a study NICU at birth or transferred within 72 hours postpartum
- Enrolled within 5 days postpartum (ideally 3 days or less)
- Plans to lactate for at least 2 weeks and initiate lactation with a breast pump
- Expected infant NICU stay of 7 or more days (ideally 14 or more days)
You will not qualify if you...
- Infant is critically ill with no expected survival or has a lethal diagnosis with plans to redirect care
- Delivered triplets or higher order multiples
- Lactation contraindications such as active chemotherapy or declines lactation initiation
- History of breast surgery affecting lactation ability (e.g., breast reduction or nipple incision augmentation)
- Using or planning to use hormonal birth control in the first 14 days postpartum
- Unable or unwilling to be in the study NICU during any of the first 5 days postpartum
- Medical team expects infant NICU stay to be less than 5 days
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
2
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
S
Samantha J. Anthony, PhD
CONTACT
R
Rebecca Hobban, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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