Status:
RECRUITING
Sodium Awareness in Lactation Trial
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
University of Washington
Conditions:
Breastfeeding
Preterm Birth
Eligibility:
FEMALE
Phase:
NA
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 poi...
Eligibility Criteria
Inclusion
- 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
- Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)
Exclusion
- 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)
- Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
- Unable/unwilling to be present in study NICU during any of first 5 days postpartum
- Presumption by the medical team that infant will be in study NICU for \<5 days
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06563726
Start Date
March 10 2025
End Date
March 1 2026
Last Update
May 28 2025
Active Locations (2)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
2
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195