Sodium Awareness in Lactation Trial
Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
The Hospital for Sick Children
40 participants
Mar 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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)
Exclusion Criteria7
- 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
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06563726