[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578360":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":41,"maxAge":70,"enrollmentInfo":71,"targetDuration":41,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":41,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention group","EXPERIMENTAL","Controlled hypothermia + open-label IV Sildenafil",[13],"Drug: Sildenafil Citrate (IV)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sildenafil Citrate (IV)","Controlled hypothermia initiated before 6h after birth (servo-controlled 33.5°C during 72h followed by a 12-h rewarming period up to 36.5°C), open-label IV Sildenafil Citrate (Revatio®, 10 mg\u002F12.5 mL, Pfizer) 0.4 mg\u002Fkg delivered over 3 hours, followed by a maintenance infusion at 1.6 mg\u002Fkg\u002Fday for 72h",[9],[21],"Revatio",[23],{"name":24,"affiliation":25,"role":26},"Olivier BAUD, MD, PhD","Hôpitaux Universitaires de Genève et Inserm U1141, Paris","STUDY_DIRECTOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Pierre-Louis LEGER, MD, PhD","CONTACT","01 71 73 86 13","+33","pierre-louis.leger@aphp.fr",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Adèle BELLINO","01 58 41 11 95","adele.bellino@aphp.fr",[39],{"facility":40,"status":41,"city":42,"state":41,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre",null,"Paris","75005","France","FR",{"type":47,"coordinates":48},"Point",[49,50],2.3488,48.85341,{"lat":50,"lon":49},[53,54],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":24,"role":30,"phone":41,"phoneExt":41,"email":55},"olivier.baud@aphp.fr",{"type":57,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[59],{"name":60,"class":6},"URC-CIC Paris Descartes Necker Cochin","100578360","phase-2-sildenafil-plus-hypothermia-to-treat-neonatal-encephalopathy-100578360",false,"NCT06810284","Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy","Effect of Sildenafil in Association to Hypothermia on Survival Without Brain Lesions In Term Neonates With Hypoxic-ischemic Encephalopathy (SHINE): Pharmacokinetic Study - Step 1","SHINE1","Inclusion Criteria:\n\n* 1\u002FNeonates born at or after 36 weeks' gestation, treated by therapeutic servo-controlled hypothermia for neonatal hypoxic ischemic encephalopathy.\n\nTherapeutic hypothermia should be decided according to French national guidelines.\n\n* 2\u002F Social security coverage\n* 3\u002F Informed consent of one of the two holders of parental authority.\n\nExclusion Criteria:\n\n* 1\u002F Chromosomal aberrations and major malformations evidenced after birth\n* 2\u002F Decision for \"comfort care only\" before study drug administration,\n* 3\u002F Uncontrolled hemorrhagic syndrome,\n* 4\u002F Severe hemodynamic failure at initiation, requiring at least two therapies (including either volume expansion, hydrocortisone or inotropes)\n* 5\u002F Known hypersensitivity to the active substance or to any of the excipients\n* 6\u002F Concomitant administration of nitrates or nitric oxide donors, Inhaled Nitric Oxide, other PDE5 inhibitors, inhibitors of CYP3A4\n* 7\u002F Participation in another interventional study","ALL","12 Hours",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia. This phase 2 study will prepare a large phase 3 randomized controlled trial to demonstrate the superiority of a combinatory therapy associating IV sildenafil and controlled hypothermia compared to Placebo and controlled hypothermia, on survival without brain lesions on MRI at discharge, in neonates born after 36 weeks of gestation.",[79],"Hypoxic-Ischemic Encephalopathy",[81,82,83,84],"Hypoxic-ischemic encephalopathy","Sildenafil","Neuroprotection","newborn","NOT_YET_RECRUITING","2026-03-30",{"date":88,"type":89},"2026-03-31","ACTUAL",{"date":91,"type":73},"2026-10",{"date":93,"type":73},"2029-05",{"name":5,"class":6},1]