[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-babies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-babies":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639874","human-milk-concentrating-device-to-optimize-mothers-own-milk-100639874",false,"NCT07576972","Human Milk Concentrating Device to Optimize Mother's Own Milk","Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk","NEOMOM","Inclusion Criteria:\n\n* Birth at 32 0\u002F7 to 34 5\u002F7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM\n* Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification\u002Fsupplementation.\n* Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Contraindication to receiving MOM\n* Feeds not started by 2 days post-birth\n* Fortification\u002Fsupplementation not ordered by 5 days post-birth,\n* Inadequate MOM for concentration\u002Ffortification within 5 days post-birth\n* Expected transfer to another hospital\n* Expected hospital discharge within 14 days post-birth\n* Enrollment in another intervention study with an intervention that could affect infant growth or mineral status\n* Infant with contraindications for use of the HMC device","ALL","32 Weeks","35 Weeks",{"count":21,"type":22},310,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.\n\nThe primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.\n\nSecondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.",[28,29],"Preterm Infant Health","Premature Babies",[31,32,33,34,35,36],"Human Milk Concentration","NICU Feeding","Neonatal nutrition","Mother's on Milk","Human Milk","Preterm infants","NOT_YET_RECRUITING","2026-05-04",{"date":40,"type":41},"2026-05-08","ACTUAL",{"date":43,"type":22},"2026-09-01",{"date":45,"type":22},"2028-07-01",{"name":47,"class":48},"Mother's Milk is Best","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100569011","intervention-for-neurodevelopmental-support-in-preterm-infants-using-responsive-parenting-and-e-health-100569011","NCT06688695","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n\\* Infant born before 32 GV, or with birth weight under 1500 gr.\n\nExclusion Criteria:\n\n* Parent(s) younger than 18 ya.\n* Chromosomal abnormalities, congenital syndromes that may affect the child's development.\n* Parents unable to understand Swedish.\n* Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.\n* Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.\n* Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.","0 Months","4 Months",{"count":61,"type":22},176,[25],"Research problem and specific questions More than 1000 very preterm infants (\\< 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan.\n\nThe overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours.\n\nThe primary research question is whether the intervention improves child neurodevelopment up to 2 years.\n\nFurther research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects.\n\nData and method Using a multi-professional approach, the study team have developed a post-discharge \"Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health\" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period.\n\nThe study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age.\n\nSocietal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program.\n\nPlan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities",[65,29],"Premature Infant",[67,68,69,70],"Early intervention","Responsive parenting","E-health","Prematurity","RECRUITING","2026-01-27",{"date":74,"type":41},"2026-01-28",{"date":76,"type":41},"2024-11-20",{"date":78,"type":22},"2029-10",{"name":80,"class":81},"Umeå University","OTHER",7]