Sodium Awareness in Lactation Trial

Recruiting now · Not applicable

Conditions studied: Breastfeeding, Preterm Birth, Breast Pumping, Lactation; Insufficient, Partial

In brief

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 facts

Study ID

NCT06563726

Run by

The Hospital for Sick Children

People needed

40

Starts

2025-03-10

Expected to finish

2026-03-01

Last updated by the study team

2025-05-28

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Consent provided
• 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
• Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
• Plans to lactate at least 2 weeks and initiate lactation with a breast pump
• Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)

You may not qualify if…

• 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
• 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)
• Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
• History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
• Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
• Unable/unwilling to be present in study NICU during any of first 5 days postpartum
• Presumption by the medical team that infant will be in study NICU for <5 days

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• University of Washington Medical Center - Montlake — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.