[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-milk-collection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-milk-collection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,74,106,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100530105","virtual-reality-distraction-for-maternal-milk-expression-pilot-100530105",false,"NCT06182449","Virtual Reality Distraction for Maternal Milk Expression (PILOT)","Feasibility, Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk (VR-MOM)","VR-MOM","Inclusion Criteria:\n\n1. speak and read French or English\n2. have given birth to a premature newborn at 29 weeks or less\n3. minimum 18 years old\n4. have chosen breastfeeding\n5. who are at least in their second week postpartum\n\nExclusion Criteria:\n\n1. Having a mental health problem or a significant cognitive disorder that prevents them from understanding the purpose of the study\n2. Having a diagnosis of epilepsy","FEMALE","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. This practice is promoted by nurses and neonatologists due to its beneficial outcomes for newborns. Compared to newborns exclusively fed commercial infant formula, preterm newborns fed breast milk (BM) are less likely to suffer from necrotizing enterocolitis and late-onset sepsis. However, the discomfort associated with using an electrical pump may discourage its use, and almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress. Therefore, virtual reality (VR), an immersive experience, seems to be an interesting option as it would provide a relaxing environment and distract mothers of newborns in NICU from the stress and discomfort experienced in order to promote breast milk expression.\n\nAim\n\nThe aim of this within-subject, pilot clinical trial is to assess the feasibility, acceptability, and preliminary effects of VR on stress, discomfort, and volume of expressed milk in mothers of preterm newborns.\n\nMethods\n\nDesign:\n\nWithin-subject, randomized pilot clinical trial in which participants are their own control.\n\nSetting and sample:\n\nLevel 3 neonatal intensive care unit (NICU) at a Montreal pediatric teaching university center. Newborns under 29 weeks of age were chose to ensure that newborns would be admitted and remain in the NICU. The objective is to recruit 20 mothers of premature newborns. This will correspond to a total sample of 40 participants as they will be their own control. There will be 50% more mothers recruited (10) to compensate for the usually high attrition or rejection rate for this population, thus a total sample of 30 mothers. Healthcare professionals (nurses and doctors) providing care to participating mothers will be asked to fill a questionnaire on the feasibility of the VR intervention.\n\nRandomization and exposure to the interventions:\n\nThe sequence of exposure to VR will be randomized, not the participants: sequence of 2 days with VR and 2 days without VR. The study will take place over the course of one week. Participating mothers will either be exposed to VR for a minimum of 2 sessions of 30 minutes\u002Fday for two days and the following two days to the control intervention or the opposite.",[27,28,29],"Anxiety","Milk Expression, Breast","Breast Milk Collection","NOT_YET_RECRUITING","2025-08-18",{"date":33,"type":34},"2025-08-24","ACTUAL",{"date":36,"type":21},"2026-01",{"date":38,"type":21},"2027-06",{"name":40,"class":41},"St. Justine's Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100579990","phase-1-excretion-of-rivaroxaban-in-human-breast-milk-100579990","NCT06831474","Excretion of Rivaroxaban in Human Breast Milk","LACT","Inclusion Criteria:\n\n1. Postpartum within 6 weeks of delivery\n2. Greater than 18 years old at expected date of delivery\n3. English speaking\n4. Hemodynamically stable without concern for ongoing blood loss\n5. Non-breastfeeding\n6. Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \\>2600g at birth and is not requiring intensive care\n7. Meet inclusion criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI \\>\u002F= 40 and\u002For any personal history of VTE. Or \\>\u002F= 2 of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy\n8. Or meet inclusion criteria for therapeutic rivaroxaban dose: have an indication for therapeutic anticoagulation per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196, or other indication per their primary team, and recommended for such anticoagulation per their primary practitioner.\n\nExclusion Criteria:\n\n1. Pregnant\n2. Less than 18 years old at estimated date of delivery\n3. Hemodynamic instability and\u002For concern for ongoing blood loss\n4. Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period\n5. Abnormal maternal renal or liver function (creatinine clearance \\\u003C 30 mL\u002Fmin and\u002For liver function tests greater than lab normal)\n6. A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding\n7. Breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \\\u003C37w0d or weighing \\\u003C2600g.\n8. If all of the following are met: age less than 40, ambulating, body mass index (BMI) less than 30, no active history of malignancy.\n9. If patient lacks indication for therapeutic anticoagulation in the postpartum period per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196",{"count":51,"type":21},10,[53],"PHASE1","The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.",[56,57,58,59,60,29],"Postpartum","VTE Prophylaxis","VTE (Venous Thromboembolism)","Rivaroxaban","Breastfeeding",[59,62,48,63],"Relative infant dose","Rivaroxaban in breast milk","RECRUITING","2025-07-14",{"date":67,"type":34},"2025-07-17",{"date":69,"type":21},"2025-07",{"date":71,"type":21},"2026-07-31",{"name":73,"class":41},"Thomas Jefferson University",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":42},"100433065","mother-infant-cohort-study-in-malaysia-and-china-100433065","NCT04919265","Mother-Infant Cohort Study in Malaysia and China","Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China","Inclusion Criteria:\n\n* Pregnant women aged between 18 and 45 years old\n* Pregnant women who attend the antenatal check-up at the selected clinics\u002Fhospitals\n* Pregnant women with the gestational age of less than 12 weeks\n* Pregnant women who plan to attend post-natal check-ups for at least one year at the same clinic\u002Fhospital\n\nExclusion Criteria:\n\n* Pregnant women who are diagnosed with immune deficiency\n* Pregnant women who have a multiple pregnancy and preterm delivery (\\\u003C37 weeks)\n* Pregnant women who plan to move out of the study area in the next one year\n* Pregnant women with fetal\u002Fnewborn with congenital abnormalities",true,"45 Years",{"count":84,"type":21},200,"OBSERVATIONAL","This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development. It also aims to determine the impact of gut microbiome on infant health (temperament, gastrointestinal symptoms, eczema symptoms, and asthma symptoms).",[88,89,90,91,92,29],"Gut Microbiota","Gastrointestinal Symptoms","Temperament","Eczema","Asthma",[94,95,96],"Gut microbiota","Mother-infant cohort study","Breastmilk","2024-12-09",{"date":99,"type":34},"2024-12-13",{"date":101,"type":34},"2022-06-03",{"date":103,"type":21},"2026-12",{"name":105,"class":41},"Universiti Putra Malaysia",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":42},"100515056","early-life-feeding-exposure-and-infant-immune-and-health-status-100515056","NCT05986539","Early Life Feeding Exposure and Infant Immune and Health Status.","Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status","Inclusion Criteria:\n\n* Mother at least 18 years of age\n* Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger\n* Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life.\n* Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.\n* Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.\n* Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.\n* Mother and infant are considered healthy by Principle Investigator.\n* For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.\n\nExclusion Criteria:\n\n* Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.\n* Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.\n* Infant was born less than 36 weeks of gestation.\n* Infant or mother have health conditions that increase the risk of study procedures.",{"count":114,"type":21},60,"Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight\u002Fobese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants.\n\nObjective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions.\n\nMethods: Healthy full-term infants (breastfed\u002Fformula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers.\n\nOutcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.",[117,118,29,119],"Maternal Behavior","Maternal Obesity","Infant Development","2024-07-24",{"date":122,"type":34},"2024-07-26",{"date":124,"type":34},"2024-01-12",{"date":126,"type":21},"2025-04-30",{"name":128,"class":41},"University of Idaho",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":81,"sex":135,"minAge":4,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":42},"100474781","omics-sequencing-of-specimen-derived-from-mother-infant-pairs-100474781","NCT05462366","Omics Sequencing of Specimen Derived From Mother-Infant-Pairs","Inclusion Criteria:\n\n* healthy pregnant women aged between 20y and 40y.\n* Vaginal birth\n* BMI\\\u003C23.5 before pregnancy\n* Infants' birth weight, between 2500g and 4000g.\n\nExclusion Criteria:\n\n* gestational diabetes\n* diagnosis of depressive disorder during pregnancy\n* gestational hypertension\n* diagnosis of other diseases during pregnancy\n* Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery\n* histrory of smoking and drinking alcohol\n* history of diarrhea from 3 months prior to pregnancy till 3 months after delivery","ALL","40 Years",{"count":138,"type":21},100,"The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.",[141,142,143],"Healthy","Breast-milk Collection","Feces","2023-07-22",{"date":146,"type":34},"2023-07-25",{"date":148,"type":34},"2021-06-22",{"date":150,"type":21},"2026-12-30",{"name":152,"class":41},"Zhujiang Hospital"]