Sodium Awareness in Lactation Trial

Launched by THE HOSPITAL FOR SICK CHILDREN · Aug 15, 2024

Keywords

ClinConnect Summary

The Sodium Awareness in Lactation Trial (SALT) is a study designed to help parents of preterm infants learn how to measure the sodium levels in their breastmilk using special devices. This is important because a drop in sodium can indicate that a mother’s body is producing enough milk for her baby, which is especially crucial for preterm infants who may need extra support. The study aims to see if parents can easily test their milk and understand the results, and it will also look at how different pumping habits and factors related to breastfeeding might affect milk production.

To be part of this study, mothers need to have delivered a preterm baby (either a single baby or twins) at less than 35 weeks of pregnancy and should be within 5 days of giving birth. They should plan to breastfeed for at least two weeks and start using a breast pump. Participants can expect to learn how to use the testing devices and provide valuable information that could help improve breastfeeding outcomes for other families in the future. It's important to know that mothers who have certain medical conditions or who have delivered more than two babies at once may not be eligible to join the study.

Gender

FEMALE

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