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NCT06563726NARecruiting

Sodium Awareness in Lactation Trial

The Hospital for Sick Children

Start Date

3/10/2025

Completion Date

3/1/2026

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

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DIAGNOSTIC_TEST

point-of-care milk sodium testing

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Conditions

BreastfeedingPreterm BirthBreast PumpingLactation; Insufficient, Partial

Locations

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States