[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"late-onset-neonatal-sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:late-onset-neonatal-sepsis":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100465939","dopamine-vs-norepinephrine-for-hypotension-in-very-preterm-infants-with-late-onset-sepsis-100465939",false,"NCT05347238","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis: An International Comparative Effectiveness Research Project","Inclusion Criteria:\n\n* ≤32 weeks gestational age and \\> 48 hours of life\n* Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection)\n\nExclusion Criteria:\n\n* Known chromosomal or genetic anomalies\n* Receiving primary therapy with agents other than Dopamine or Norepinephrine","ALL","21 Weeks","32 Weeks",{"count":20,"type":21},550,"ESTIMATED","36 Weeks","OBSERVATIONAL","Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring \\>48 hours of age). In Canada, \\~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \\~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices.\n\nAim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS.\n\nObjective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS.\n\nHypothesis: Primary treatment with NE will be associated with a lower mortality\n\nMethods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 16 centers in Canada, 2 centers in Ireland, 1 center in each of Israel, Spain and the UK, and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc\u002Fkg). If hypotension remains unresolved:\n\nDopamine Units: start at 5mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 5 mics\u002Fkg\u002Fmin to a maximum dose of 15 mics\u002Fkg\u002Fmin or adequate response\n\nNorepinephrine Units: start at 0.05 mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 0.05 mics\u002Fkg\u002Fmin to maximum dose of 0.15\u002Fmics\u002Fkg\u002Fmin or adequate response",[26,27,28],"Late-Onset Neonatal Sepsis","Extreme Prematurity","Neonatal Hypotension","RECRUITING","2025-07-03",{"date":32,"type":33},"2025-07-08","ACTUAL",{"date":35,"type":33},"2023-02-06",{"date":37,"type":21},"2027-03-31",{"name":39,"class":40},"Mount Sinai Hospital, Canada","OTHER",23,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100531384","the-high-initial-dose-of-monitored-vitamin-d-supplementation-in-preterm-infants-100531384","NCT06199102","The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.","The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.","HIDVID","Inclusion Criteria:\n\n* preterm infants with a gestational age of 24+0\u002F7 to 32+6\u002F7 born at our clinic\n* preterm infants with a gestational age of 24+0\u002F7 to 32+6\u002F7 outborn and admitted to our intensive care unit within 48h after delivery\n* written informed consent form caregivers for the mother and the child to participate in the study\n\nExclusion Criteria:\n\n* infants born at \\>32 weeks of gestation\n* infants with major congenital abnormalities or other severe congenital malformations\n* infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival\n* infants with diagnosed cholestasis\n* the absence of written informed consent and challenges in communication with caregivers","1 Day","2 Days",{"count":53,"type":21},130,"INTERVENTIONAL",[56],"NA","The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.",[59,60,61,62,26],"Vitamin D Deficiency","Osteopenia of Prematurity","Nephrolithiasis","Metabolic Bone Disease",[64,65,66,67,68],"vitamin D","preterm infants","osteopenia of prematurity","late-onset sepsis","metabolic bone disease","NOT_YET_RECRUITING","2024-01-09",{"date":72,"type":33},"2024-01-10",{"date":74,"type":21},"2024-09-01",{"date":76,"type":21},"2027-12-31",{"name":78,"class":40},"Princess Anna Mazowiecka Hospital, Warsaw, Poland",1,"Late Onset Neonatal Sepsis"]