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NCT Number: NCT06563726

Sodium Awareness in Lactation 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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Breast Milk Expression Breast Pumping Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Lactation; Insufficient, Partial Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital, Seattle, Washington, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

point-of-care milk sodium testing

Diagnostic 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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).

    Time frame: Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)

    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.

  2. Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)

    Time frame: First 14 days postpartum

    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.

Other outcomes

  1. Explore if POC Na data used to recommend changes in pumping behaviour is associated with actual changes in parent pumping behaviour

    Time frame: First 14 days postpartum

    Explore in parents whom we recommend to modify pumping frequency, rates of coming to volume by day 14 (pumping at least 500mL/day)

  2. Explore how POC Na data used to recommend changes in pumping behaviour is associated with short-term milk volumes

    Time frame: First 14 days postpartum

    Determine in parents whom we recommend to modify pumping frequency based on POC Na, how often they actually followed our recommendations

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Hobban, MD, MPH

CONTACT

[email protected]

Samantha J. Anthony, PhD

CONTACT

[email protected]

(416) 813-7654 ext. 303126

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • University of Washington

Registry information

Official study title

Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers

Acronym: SALT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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