| NCT ID | NCT06563726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Breastfeeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-03-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Samantha J. Anthony, PhD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT06563726 clinical trial?
This trial is open to female participants only, studying Breastfeeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06563726 currently recruiting?
Yes, NCT06563726 is actively recruiting participants. Contact the research team at samantha.anthony@sickkids.ca for enrollment information.
Where is the NCT06563726 trial being conducted?
This trial is being conducted at Seattle, United States, Seattle, United States.
Who is sponsoring the NCT06563726 clinical trial?
NCT06563726 is sponsored by The Hospital for Sick Children. The principal investigator is Samantha J. Anthony, PhD at The Hospital for Sick Children. The trial plans to enroll 40 participants.