Teaching parents to test breastmilk sodium levels in preterm infants
Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
This study is testing if teaching parents how to check the sodium levels in their breastmilk can help improve milk production for their preterm babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | Female |
| Sponsor | The Hospital for Sick Children Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT06563726 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are lactating parents of preterm infants born at less than 35 weeks gestation who plan to initiate lactation with a breast pump.
Not a fit: Patients whose infants are critically ill or have lethal diagnoses, or those with contraindications to lactation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved lactation outcomes and milk volumes for parents of preterm infants.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.