NCT06563726 · The Hospital for Sick Children
Sodium Awareness in Lactation Trial
(SALT)
What this study is about
SALT is a multi-centre, non-blinded, non-randomly assigned forward-looking 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
point-of-care milk sodium testing
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.
Primary outcome measures
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
Time frame: First 14 days postpartum
We will collect time cost of milk testing, including teaching parents how to test milk and daily time testing milk. This outcome will include time (in hours) spent in the first 14 days for parent and staff, with a health economist determining costs for that time
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews
Time frame: First 14 days postpartum
We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys
Time frame: First 14 days postpartum
We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
- Seattle, Washington
Collaborators
University of Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2025 · Source of record for eligibility and locations