[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539604":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":60,"collaborators":41,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":41,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":41,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":88,"whyStopped":41,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylene blue","EXPERIMENTAL","Subjects in the intervention arm will receive a 1 mg\u002Fkg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg\u002Fkg\u002Fh. The infusion rate may be increased in steps of 0.15 mg\u002Fkg\u002Fh every 30 minutes until a maximum of 0.5 mg\u002Fkg\u002Fh.",[13],"Drug: Methylene Blue",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo infusion","PLACEBO_COMPARATOR","Subjects in the control arm will receive a placebo infusion (normal saline) at the same volumetric rate.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Methylene Blue",[9],[26],"MB",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo","Subjects in the placebo arm will receive normal saline in the same volumetric dose as methylene blue in the intervention arm",[15],[32],"Normal saline",[34],{"name":35,"affiliation":5,"role":36},"Sourabh Dutta, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+91-1722755313",null,"sourabhdutta1@gmail.com",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Sajan Saini, MD, DM","+91-1722756264","sajansaini1@gmail.com",[48],{"facility":49,"status":41,"city":50,"state":41,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":41},"Post Graduate Institute of Medical Education and Research (PGIMER)","Chandigarh","160012","India","IN",{"type":55,"coordinates":56},"Point",[57,58],76.7884,30.73629,{"lat":58,"lon":57},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Sourabh Dutta","Professor","100539604","phase-2-intravenous-methylene-blue-for-treating-refractory-neonatal-septic-shock-100539604",false,"NCT06306001","Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock","Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial","Screening Criteria: preterm infants (\\\u003C37 weeks, \\\u003C28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following\n\n1. Definite\u002Fprobable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein \\>10 mg\u002FdL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists.\n2. Shock: adapted from the definition given by Davis et al 2017\n\n   1. Either SBP \\\u003C age and gestation appropriate cut-off OR\n   2. Presence of any 2 of the following 6 parameters i. HR \\>205\u002Fmin ii. Central pulses either week OR bounding iii. CRT \\>3 sec OR flash refill (\\\u003C1 sec) iv. skin mottled\u002Fcool OR flushed v. urine output \\\u003C0.5 ml\u002Fkg\u002Fh in the preceding 6 hours vi. DBP \\\u003C age and gestation appropriate cut-off\n3. Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml\u002Fkg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg\u002Fkg\u002Fmin) or epinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin) or norepinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin).\n\nExclusion Criteria:\n\nexcluded if ≥1 criterion positive:\n\n1. G6PD deficient or family history of G6PD deficiency\n2. Potentially lethal malformation\n3. Congenital heart disease\n4. Severe acute kidney injury\n5. Family history of allergy to methylene blue or food dyes","ALL","0 Days","28 Days",{"count":74,"type":75},130,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:\n\n1. Whether MB treatment reduces death to any cause as compared to no MB treatment.\n2. Whether treatment with MB reduces the time to achieve normal blood pressure\n3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.\n4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.",[82,83],"Neonatal Sepsis","Shock, Septic",[9,85,86,87],"Neonate","Septic shock","Clinical trial","NOT_YET_RECRUITING","2024-03-05",{"date":91,"type":92},"2024-03-12","ACTUAL",{"date":94,"type":75},"2024-03-15",{"date":96,"type":75},"2027-02",{"name":5,"class":6},1]