[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-milk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-milk":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100519381","umbrellact-study-clinical-lactation-study-on-the-exposure-to-medicines-via-human-milk-100519381",false,"NCT06042803","UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk","Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol","UmbrelLACT","Inclusion Criteria:\n\n* For breastfeeding women\n\n  * Maternal age: ≥ 18 year\n  * Currently exclusively or partially breastfeeding (\u002Fexpressing milk) at the time of milk sampling\n  * Using medicines for any indication, with at least 5 half-lives of the medicine taken\n  * Willing to express and collect human milk\n  * Signed informed consent to participate and for processing their personal data\n* For infants\n\n  * Gestational age at birth: ≥24 weeks\n  * Parental signed informed consent to participate and for processing their personal data\n\nExclusion Criteria:\n\n* Maternal age \\\u003C18 years\n* Mother of twins\n* Not meeting the inclusion criteria",true,"FEMALE","18 Years",{"count":21,"type":22},30,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are:\n\n* What is the concentration of maternal medicines in human milk?\n* What is the (estimated) intake and exposure in the breastfed infant?\n\nParticipants will be asked to\n\n* fill out a questionnaire regarding medical data of the mother and child\n* track medication intake for 3 days\n* collect milk samples during 24 hours\n* optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child\n* fill out a questionnaire regarding the general health of the child.",[26,27],"Breast Feeding","Human Milk",[29,30,31,32,33,34,35,36],"Infant exposure","Physiologically-based pharmacokinetic models","Neonatology","breastfeeding","Pharmacology","Medicines","Drug transfer","Medication intake","RECRUITING","2025-02-24",{"date":40,"type":41},"2025-02-27","ACTUAL",{"date":43,"type":41},"2023-02-01",{"date":45,"type":22},"2027-02",{"name":47,"class":48},"Universitaire Ziekenhuizen KU Leuven","OTHER"]