Sodium Awareness in Lactation Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
The Hospital for Sick Children
Study ID
NCT06563726
Status
Recruiting
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Conditions

  • Breast Pumping
  • Breastfeeding
  • Lactation; Insufficient, Partial
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • point-of-care milk sodium testing — DIAGNOSTIC_TEST
    Data-driven interventions to improve early lactation success are lacking, and parents who deliver preterm are at high risk of lactation challenges. We will be studying feasibility, acceptability, and time cost of teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. As a secondary aim, we will assess the potential to use these POC sodium results to guide personalized lactation care in the form of altered pumping schedules in an attempt to reduce breastmilk Na. 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.

Study Details

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

Key Dates

Start date
Mar 10, 2025
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Primary Outcome Measure

Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic [ Time Frame: First 14 days postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Debbie Ng, MPH
[email protected]
University of Washington Medical Center - MontlakeSeattleWashington98195
Debbie Ng, MPH
[email protected]

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By research site
Seattle Children's Hospital· Seattle, WAUniversity of Washington Medical Center - Montlake· Seattle, WA

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