Sodium Awareness in Lactation Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe Hospital for Sick Children
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- point-of-care milk sodium testing
Treatment groups
No treatment groups listed
Sponsors and collaborators
The Hospital for Sick Children
Lead sponsor
University of Washington
Collaborator
Source ClinicalTrials.gov