Sodium Awareness in Lactation Trial (NCT06563726) | Clinical Trial Compass
RecruitingNot Applicable
Sodium Awareness in Lactation Trial
United States40 participantsStarted 2025-03-10
Plain-language 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
Who can participate
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
Timeframe: First 14 days postpartum
2
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews
Timeframe: First 14 days postpartum
3
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys