[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569400":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Brain contrast-enhanced ultrasound","EXPERIMENTAL","The study duration per subject will be up to 30 minutes including the time to prepare the contrast agent, perform the pre-contrast imaging and the contrast-enhanced ultrasound (CEUS), as well as the 60-minute monitoring period after the administration of the contrast agent. A second CEUS exam may be performed within 1-2 weeks from the first scan for up to two CEUS exams of 1 hour and 30-minute duration each. Study participation will be complete when the 60-minute monitoring period of the last CEUS performed is complete.",[13],"Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]","Injection of Sulfur hexafluoride lipid-type A microspheres contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg\u002Fkg before performing the contrast-enhanced ultrasound. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Misun Hwang, MD","CONTACT","267-425-7110","hwangm@chop.edu",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Maria Mezher, MD","267-425-5821","mezherm@chop.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-75.16362,39.95238,{"lat":43,"lon":42},[46,47,48],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":49,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":23,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sponsor Investigator","100569400","phase-2-ceus-evaluation-of-hydrocephalus-in-neonates-and-infants-100569400",false,"NCT06693752","CEUS Evaluation of Hydrocephalus in Neonates and Infants","Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound","Inclusion Criteria:\n\n1. Males and females younger than 1.5 years old with diagnosed and\u002For suspected hydrocephalus.\n2. Post menstrual age of 26 weeks or older.\n3. Inpatients at the Children's Hospital of Philadelphia.\n4. Parental\u002FLegally authorized representative permission.\n\nExclusion Criteria:\n\n1. Medical history of Lumason hypersensitivity.\n2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team.\n3. Respiratory instability as defined by rapid escalation of respiratory support in the past 12-24 hours (Increased fraction of inspired oxygen (FiO2) requirement and\u002For nitric oxide).","ALL","1 Minute","18 Months",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and\u002For suspected hydrocephalus.",[70,71],"Hydrocephalus in Infants","Hydrocephalus Acquired",[73,74,75],"Ultrasound","Contrast-enhanced ultrasound","Infant hydrocephalus","2026-06-22",{"date":78,"type":79},"2026-06-25","ACTUAL",{"date":81,"type":64},"2026-07-15",{"date":83,"type":64},"2028-08-01",{"name":5,"class":6},1]