Sodium Awareness in Lactation Trial

ConditionsBreastfeeding Preterm Birth Breast Pumping Lactation; Insufficient, Partial

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

AgeNot listed

SponsorThe Hospital for Sick Children

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial 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

Other outcomes

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

Explore in parents whom we recommend to modify pumping frequency, rates of coming to volume by day 14 (pumping at least 500mL/day)

Time frame

First 14 days postpartum

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

Determine in parents whom we recommend to modify pumping frequency based on POC Na, how often they actually followed our recommendations

Time frame

First 14 days postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

University of Washington

Collaborator

Source ClinicalTrials.gov

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