Sodium Awareness in Lactation Trial

Not Applicable

Recruiting

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

• Registration Number: NCT06563726
• Lead Sponsor: The Hospital for Sick Children

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-21
• Study Start: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic	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
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews	First 14 days postpartum	We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys	First 14 days postpartum	We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys

Secondary Outcome Measures

Name	Time	Method
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)	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.
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	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.

Trial Locations

Locations (2)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Washington Medical Center - Montlake; 🇺🇸 Seattle, Washington, United States