[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-hypotension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-hypotension":28},{"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":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100535860","phase-4-appropriate-dosage-of-vasopressor-in-neonates-and-infants-100535860","NCT06257316","Appropriate Dosage of Vasopressor in Neonates and Infants","A Study on the Appropriate Dosage of Vasopressors to Maintain Adequate Cerebral Blood Flow During Surgery and Anesthesia in Neonates and Infants","Inclusion Criteria:\n\n* Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital\n\nExclusion Criteria:\n\n* Premature infants with a gestational age of less than 37 weeks\n* Children with a history of brain disease (hydrocephalus, brain tumor, etc.)\n* Patients with a history of hypoxic\u002Fischemic brain injury\n* Children with fused fontanels\n* Children with uncorrected congenital cardiac malformations such as patent ductus arteriosus\n* Patients with hypersensitivity to ephedrine and its components\n* Patients with hypertension\n* Patients with thyrotoxicosis\n* Patients with renal impairment and those taking thyroid medication\n* Glaucoma patients\n* Diabetic patients\n* Patients with prostatic hyperplasia\n* Patients with chromophobe cell tumors\n* Patients taking or within 2 weeks of discontinuing monoamine oxidase inhibitors\n* Patients with ischemic heart disease\n* Patients receiving foxglove preparations\n* Patients with cardiac disease\n* Patients receiving inotropic agents and those with abnormal baseline blood pressure\n* Those who are taking or need to take concomitant contraindicated medications\n* Those who require halogenated anesthetics such as chloroform, cyclopropane, and halothane because concomitant administration may cause ventricular arrhythmias.\n* Those who are expected to require these agents because they may cause arrhythmias or cardiac arrest when coadministered with catecholamines such as epinephrine and isoproterenol.","2 Years",{"count":51,"type":21},132,"INTERVENTIONAL",[54],"PHASE4","In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.",[57,28,58],"Hypotension","Intraoperative Complications","NOT_YET_RECRUITING","2024-02-13",{"date":62,"type":33},"2024-02-15",{"date":62,"type":21},{"date":65,"type":21},"2028-02-28",{"name":67,"class":40},"Seoul National University Hospital"]