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Sodium Awareness in Lactation Trial (SALT)

T

The Hospital for Sick Children

Status

Enrolling

Conditions

Breast Pumping
Lactation; Insufficient, Partial
Breastfeeding
Preterm Birth

Treatments

Diagnostic Test: point-of-care milk sodium testing

Study type

Interventional

Funder types

Other

Identifiers

NCT06563726
PJM-185757

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Samantha J. Anthony, PhD; Rebecca Hobban, MD, MPH

Data sourced from clinicaltrials.gov

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