BreastfeedingSALTNCT06563726
Sodium Awareness in Lactation Trial
A study testing point-of-care milk sodium testing in people with Breastfeeding and Preterm Birth, run by The Hospital for Sick Children at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Preterm Birth, Breast Pumping
- What is being tested?
- point-of-care milk sodium testing
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2025to Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Hobban, MD, MPH contact
United States2 sites, 2 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Debbie Ng, MPH, ngdm@uw.edu
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Debbie Ng, MPH, ngdm@uw.edu
About this study
Official title: Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
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
Read more
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
- Being tested
- point-of-care milk sodium testing
- Medical subject headings
- Breast Feeding, Premature Birth, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of-care milk sodium testingDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
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
Measured: First 14 days postpartum
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews
We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews
Measured: First 14 days postpartum
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys
We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys
Measured: First 14 days postpartum
Secondary outcomes (2)
Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).
We will assess interrelationships between aforementioned factors and milk provision at NICU discharge (exclusive, any, none). Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcome cannot be separated.
Measured: Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)
Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)
We will assess interrelationships between aforementioned factors and coming to volume (pumping at least 500mL/day by postpartum day 14).Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcomes cannot be separated.
Measured: First 14 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multi-centre, non-blinded, non-randomized prospective interventional pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Samantha Anthony, The Hospital for Sick Children
- Investigators
- Samantha J. Anthony, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563726
- Sponsor's protocol ID
- PJM-185757
- Acronym
- SALT
- Status last verified
- May 2025
- First submitted
- 8 Aug 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No