Sodium Awareness in Lactation Trial

The Hospital for Sick Children40 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breastfeeding Preterm Birth Breast Pumping Lactation; Insufficient, Partial

Interventions

point-of-care milk sodium testingDIAGNOSTIC_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

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: First 14 days postpartum

Secondary Outcomes

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

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.

Time frame: 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)

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.

Time frame: First 14 days postpartum

Sodium Awareness in Lactation Trial

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts