[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493287":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":10,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Novlead Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nitric Oxide",null,"Inhaled Nitric Oxide",[13],"Device: Nitric Oxide Generator and Delivery System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Nitric Oxide Generator and Delivery System","Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.",[9],[21],{"name":22,"affiliation":23,"role":24},"Bin Wang","Southern Medical University, China","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Zhou Fang","CONTACT","+8615655595707","zhou.fang@novlead.com",[32],{"facility":33,"status":34,"city":35,"state":35,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"ZhuJiang Hospital of Southern Medical University","RECRUITING","Guangzhou","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},[45],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100493287","a-real-world-study-of-nitric-oxide-generator-and-delivery-system-100493287",false,"NCT05703191","A Real-world Study of Nitric Oxide Generator and Delivery System","The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study","Inclusion Criteria:\n\n1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians\n2. Admitted to the Department of Neonatology at the hospital, gender unlimited\n3. Diagnosed as pulmonary hypertension and undergoing\u002Fdecided to undergo respiratory support\n4. Documented Oxygenation index (OI) ≥8 prior to the treatment\n5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study\n\nExclusion Criteria:\n\n1. Proven risks of nitric oxide contraindication\n2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation\n3. Other circumstances that investigators believe unsuitable for enrollment","ALL",{"count":57,"type":58},10,"ESTIMATED","OBSERVATIONAL","The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.",[62],"Pulmonary Hypertension of Newborn","2025-02-14",{"date":65,"type":66},"2025-02-19","ACTUAL",{"date":68,"type":66},"2023-02-03",{"date":70,"type":58},"2025-05-31",{"name":5,"class":6},1]