[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559407":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":53,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":7,"maxAge":7,"enrollmentInfo":68,"targetDuration":7,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":7,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","point-of-care milk sodium testing","Data-driven interventions to improve early lactation success are lacking, and parents who deliver preterm are at high risk of lactation challenges. We will be studying feasibility, acceptability, and time cost of teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. As a secondary aim, we will assess the potential to use these POC sodium results to guide personalized lactation care in the form of altered pumping schedules in an attempt to reduce breastmilk Na. 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.",[14],{"name":15,"affiliation":5,"role":16},"Samantha J. Anthony, PhD","PRINCIPAL_INVESTIGATOR",[18,23],{"name":15,"role":19,"phone":20,"phoneExt":21,"email":22},"CONTACT","(416) 813-7654","303126","samantha.anthony@sickkids.ca",{"name":24,"role":19,"phone":7,"phoneExt":7,"email":25},"Rebecca Hobban, MD, MPH","Rebecca.Hoban@seattlechildrens.org",[27,45],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Seattle Children's Hospital","RECRUITING","Seattle","Washington","98105","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-122.33207,47.60621,{"lat":39,"lon":38},[42],{"name":43,"role":19,"phone":7,"phoneExt":7,"email":44},"Debbie Ng, MPH","ngdm@uw.edu",{"facility":46,"status":29,"city":30,"state":31,"zip":47,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"University of Washington Medical Center - Montlake","98195",{"type":36,"coordinates":49},[38,39],{"lat":39,"lon":38},[52],{"name":43,"role":19,"phone":7,"phoneExt":7,"email":44},{"type":16,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Samantha Anthony","Health Clinician Scientist, Associate Professor",[57],{"name":58,"class":6},"University of Washington","100559407","sodium-awareness-in-lactation-trial-100559407",false,"NCT06563726","Sodium Awareness in Lactation Trial","Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers","SALT","Inclusion Criteria:\n\n1. Consent provided\n2. Have delivered a preterm singleton or twin infant at \\\u003C35 weeks gestation admitted to a study NICU at birth or transferred into a study NICU from another NICU within the first 72 hours postpartum\n3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)\n4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump\n5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)\n\nExclusion Criteria:\n\n1. Potential study participant's infant is critically ill and not expected to survive or has lethal diagnosis with plans by medical team\u002Ffamily to redirect care\n2. 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)\n3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation\n4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)\n5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation\u002Flactation\n6. Unable\u002Funwilling to be present in study NICU during any of first 5 days postpartum\n7. Presumption by the medical team that infant will be in study NICU for \\\u003C5 days","FEMALE",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.\n\nPrimary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum\n\nSecondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes\n\nExploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes",[76,77,78,79],"Breastfeeding","Preterm Birth","Breast Pumping","Lactation; Insufficient, Partial","2025-05-27",{"date":82,"type":83},"2025-05-28","ACTUAL",{"date":85,"type":83},"2025-03-10",{"date":87,"type":70},"2026-03",{"name":5,"class":6},2]