Sodium Awareness in Lactation Trial

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. 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

Conditions

Breastfeeding, Preterm Birth, Breast Pumping, Lactation; Insufficient, Partial

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

Sodium Awareness in Lactation Trial

Condition
Breastfeeding
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington Medical Center - Montlake, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Consent provided
  • 2. 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
  • 3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
  • 4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump
  • 5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)
  • 1. 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
  • 2. 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)
  • 3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
  • 4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
  • 5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
  • 6. Unable/unwilling to be present in study NICU during any of first 5 days postpartum
  • 7. Presumption by the medical team that infant will be in study NICU for \<5 days

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Hospital for Sick Children,

Samantha J. Anthony, PhD, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children

Study Record Dates

2026-03