[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06563726":3,"trial-entities:NCT06563726":99,"trial-summary:NCT06563726":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":47,"sex":55,"minimum_age":17,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":64,"central_contacts":85,"overall_officials":94,"references":97,"see_also_links":98},"NCT06563726","PJM-185757","Sodium Awareness in Lactation Trial","Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers","RECRUITING","2026-03","2025-05","2025-05-28","2025-03-10","The Hospital for Sick Children","OTHER",false,"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",null,[19,20,21,22],"Breastfeeding","Preterm Birth","Breast Pumping","Lactation; Insufficient, Partial",[],"INTERVENTIONAL","DIAGNOSTIC",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35},"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.",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic","We will collect time cost of milk testing, including teaching parents how to test milk and daily time testing milk. This outcome will include time (in hours) spent in the first 14 days for parent and staff, with a health economist determining costs for that time","First 14 days postpartum",{"measure":42,"description":43,"timeFrame":40},"Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews","We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews",{"measure":45,"description":46,"timeFrame":40},"Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys","We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys",[48,52],{"measure":49,"description":50,"timeFrame":51},"Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).","We will assess interrelationships between aforementioned factors and milk provision at NICU discharge (exclusive, any, none). Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcome cannot be separated.","Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)",{"measure":53,"description":54,"timeFrame":40},"Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)","We will assess interrelationships between aforementioned factors and coming to volume (pumping at least 500mL\u002Fday by postpartum day 14).Note these are not necessarily correlations, but relationships and associations that we will analyze and explore in various models and combinations, so these outcomes cannot be separated.","FEMALE",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"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",[61,62,63],"CHILD","ADULT","OLDER_ADULT",[65,79],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":76},"Seattle Children's Hospital","Seattle","Washington","98105","United States",[72],{"name":73,"role":74,"email":75},"Debbie Ng, MPH","CONTACT","ngdm@uw.edu",{"lat":77,"lon":78},47.60621,-122.33207,{"facility":80,"status":8,"city":67,"state":68,"zip":81,"country":70,"contacts":82,"geoPoint":84},"University of Washington Medical Center - Montlake","98195",[83],{"name":73,"role":74,"email":75},{"lat":77,"lon":78},[86,91],{"name":87,"role":74,"phone":88,"phoneExt":89,"email":90},"Samantha J. Anthony, PhD","(416) 813-7654","303126","samantha.anthony@sickkids.ca",{"name":92,"role":74,"email":93},"Rebecca Hobban, MD, MPH","Rebecca.Hoban@seattlechildrens.org",[95],{"name":87,"affiliation":13,"role":96},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101,20],"Hypogalactia",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is a multi-center, non-blinded, non-randomized interventional pilot study involving 40 participants. It focuses on teaching parents to use a diagnostic test for breast milk sodium.","completed","Sodium Awareness in Lactation Trial (SALT)","This study, called SALT, is looking at how parents of premature babies can test their breast milk for sodium (Na) using a small, portable device. A drop in sodium levels in breast milk is a good sign that the body is making enough milk. The study aims to see if it's practical and acceptable for parents to do these tests themselves during the first 14 days after birth. Researchers also want to understand how these daily sodium levels relate to pumping habits and how much milk is produced. You may be able to join if you've recently delivered a premature baby (under 35 weeks gestation) and are within 5 days postpartum. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","The primary endpoints are measured within the first 14 days postpartum.",126,"Participants will be taught how to test their breast milk sodium using point-of-care meters during the first 14 days postpartum. Parent acceptance will be measured through interviews and surveys.","Not stated in the trial record.",[],"v2"]