An interventional study of point-of-care milk sodium testing in Breastfeeding, Preterm Birth and Breast Pumping, sponsored by The Hospital for Sick Children. Recruiting at 2 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic
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
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
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
Time frame: 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
Time frame: 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
Time frame: First 14 days postpartum
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.
Time frame: 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.
Time frame: First 14 days postpartum
Explore if POC Na data used to recommend changes in pumping behaviour is associated with actual changes in parent pumping behaviour
Explore in parents whom we recommend to modify pumping frequency, rates of coming to volume by day 14 (pumping at least 500mL/day)
Time frame: First 14 days postpartum
Explore how POC Na data used to recommend changes in pumping behaviour is associated with short-term milk volumes
Determine in parents whom we recommend to modify pumping frequency based on POC Na, how often they actually followed our recommendations
Time frame: First 14 days postpartum
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Plan to share: No
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