40 Participants Needed

Sodium Awareness for Premature Birth

(SALT Trial)

Recruiting at 1 trial location
SJ
RH
Overseen ByRebecca Hobban, MD, MPH
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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 postpartumSecondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomesExploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes

Research Team

SJ

Samantha J. Anthony, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

The SALT study is for lactating parents with preterm infants (<35 weeks gestation) in the NICU. Participants must consent, be within 5 days postpartum, plan to pump breast milk for at least 2 weeks, and expect their infant's NICU stay to be over a week.

Inclusion Criteria

I have given my consent to participate.
I gave birth to a preterm baby before 35 weeks who was admitted to a NICU.
I plan to breastfeed and start using a breast pump within 2 weeks.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are taught to test their breastmilk sodium using point-of-care meters and modify pumping behavior based on sodium levels

2 weeks
Daily interactions (in-person or virtual)

Follow-up

Participants are monitored for lactation outcomes and milk provision at NICU discharge

Up to 52 weeks

Treatment Details

Interventions

  • Parent-led Parent Milk Sodium Testing
Trial Overview This pilot study teaches participants how to test breastmilk sodium levels using POC meters. It aims to determine if this practice is feasible and acceptable, and whether it can influence pumping behavior and improve lactation outcomes.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+
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