NCT06563726

Sodium Awareness in Lactation Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	point-of-care milk sodium testing	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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-08-21
• Last updated: 2025-05-28

Locations

2 sites across 1 country: United States