Teaching parents to test breastmilk sodium levels in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study focuses on educating lactating parents of hospitalized preterm infants on how to measure the sodium content in their breastmilk using point-of-care meters. The study aims to establish the feasibility and acceptance of parent-led sodium testing within the first two weeks postpartum. It will also explore the relationship between pumping behaviors, lactation risk factors, and sodium levels in breastmilk to improve lactation outcomes. The goal is to empower parents with knowledge that may enhance milk production for their vulnerable infants.

Why it matters

Who can join: the full rules

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

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• University of Washington Medical Center - Montlake
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Samantha J. Anthony, PhD — The Hospital for Sick Children
• Study coordinator: Samantha J. Anthony, PhD
• Email: samantha.anthony@sickkids.ca
• Phone: (416) 813-7654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.