[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-complication":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413",false,"NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","ALL","0 Hours","48 Hours",{"count":21,"type":22},1444,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[28,29,30,31,32,33,34],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Neonatal Intensive Care Unit","Breastfeeding","Mental Health Issue",[36,37],"Pasteurised donor human milk","Donor breastmilk","RECRUITING","2026-01-29",{"date":41,"type":42},"2026-02-02","ACTUAL",{"date":44,"type":42},"2025-12-04",{"date":46,"type":22},"2028-12",{"name":48,"class":49},"The University of Queensland","OTHER",4,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100564076","effectiveness-of-a-pragmatic-metabolic-care-clinic-for-patients-with-severe-mental-illness---the-meta-care-clinic-100564076","NCT06624462","Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic","Inclusion Criteria:\n\n* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)\n* Medical treatment with antipsychotics\n* Age 18-45 years\n* Legally competent\n* Able to give informed consent\n\nand either:\n\n\\- Body mass index (BMI) ≥30 kg\u002Fm2.\n\nOr\n\n* BMI ≥27 kg\u002Fm2 and at least one of the following:\n* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office \u002F 24-hour, non-invasive ambulatory blood pressure ≥140\u002F90 mmHg within the previous 6 months\n* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol\u002Fl), elevated triglycerides (≥1.7 mmol\u002Fl) or low high-density lipoprotein cholesterol (≥1.2 mmol\u002Fl in women and ≥1.0 mmol\u002Fl in men) within the previous 6 months\n* Sleep apnoea (ICD-10 DG473).\n* Prediabetes or diabetes defined as HbA1c ≥42 mmol\u002Fmol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.\n\nOr\n\n\\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.\n* Unstable psychiatric disorder as judged by the research team.\n* Severe current drug or alcohol misuse as judged by the research team.\n* Acute suicidal risk.","18 Years","45 Years",{"count":60,"type":22},84,[62],"NA","This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness",[65,29,66,67,68],"Severe Mental Disorder","Side-Effect;Medication","Schizophrenia Spectrum and Other Psychotic Disorders","Bipolar Disorder",[70,71,72,73,74,75],"Severe mental illness","Overweight and obesity","Antipsychotic medication","Dysmetabolism","Schizophrenia Spectrum Disorders","Bipolar disorder","2026-01-06",{"date":78,"type":42},"2026-01-08",{"date":80,"type":42},"2023-10-10",{"date":82,"type":22},"2026-12-31",{"name":84,"class":49},"Bjorn H. Ebdrup",1]