RECRUITING

Sodium Awareness in Lactation Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-03-10
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06563726

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Consent provided
  2. 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. 3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
  4. 4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump
  5. 5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)
  1. 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. 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. 3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
  4. 4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
  5. 5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
  6. 6. Unable/unwilling to be present in study NICU during any of first 5 days postpartum
  7. 7. Presumption by the medical team that infant will be in study NICU for \<5 days

Contacts and Locations

Study Contact

Samantha J. Anthony, PhD
CONTACT
(416) 813-7654
samantha.anthony@sickkids.ca
Rebecca Hobban, MD, MPH
CONTACT
Rebecca.Hoban@seattlechildrens.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: The Hospital for Sick Children

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

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