Sodium Awareness in Lactation Trial

NCT06563726 | Recruiting

• 1 other identifier: PJM-185757
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

  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)

  First 14 days postpartum

Other Outcomes (2)

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

  First 14 days postpartum

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

  First 14 days postpartum

Interventions

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University of Washington: collaborator

Study Sites (2)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Premature Birth; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Samantha J. Anthony, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha J. Anthony, PhD

CONTACT

(416) 813-7654; samantha.anthony@sickkids.ca

Rebecca Hobban, MD, MPH

CONTACT

Rebecca.Hoban@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Clinician Scientist, Associate Professor

Model Details: multi-centre, non-blinded, non-randomized prospective interventional pilot study

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 21, 2024
• Study Start: March 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)