Sodium Awareness in Lactation Trial
NCT Number: NCT06563726
Acronym: SALT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastfeeding|Preterm Birth|Breast Pumping|Lactation; Insufficient, Partial
Interventions: DIAGNOSTIC_TEST: point-of-care milk sodium testing
Sponsor: The Hospital for Sick Children
Collaborators: University of Washington
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-05

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

Primary Outcome Measures: 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, 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, 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, First 14 days postpartum
Secondary Outcome Measures: 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., 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., First 14 days postpartum
Other Outcome Measures: 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), 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, First 14 days postpartum