[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498217":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":106,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":20,"eligibilityCriteria":120,"healthyVolunteers":117,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":20,"studyType":127,"phases":128,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":97,"whyStopped":20,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University of Utah","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","Maternal Hyperoxia (MH) will be administered to pregnant patients after their standard of care fetal echocardiogram has been performed at their scheduled fetal cardiology visit at ³28 weeks gestation. The evaluation at ³28 weeks was chosen since gestational age impacts both the cardiovascular and cerebrovascular response to MH.31 The evaluation will extend the duration of the visit by approximately 30 minutes but additional evaluations or visits for the study will not be required.",[13,14],"Procedure: Single Arm","Procedure: Neonatal Neurobehavioral Scale",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","* Phase 1- Baseline: A fetal echocardiogram will be performed as part of routine standard clinical care.\n* Phase 2- MH: The participant will be placed on 8 litres of 100% FiO2 (inspired oxygen fraction) via a non-rebreather face mask for 10 minutes. After 10 minutes, additional images will be obtained. MH will be discontinued after additional imaging is complete.\n* Phase 3- Recovery: After at least 5 minutes of discontinuation of MH, additional images will be obtained to ensure any changes have returned back to baseline.",[9],null,{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Neonatal Neurobehavioral Scale","Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) evaluation: All neonates with CHD expected to undergo neonatal cardiac intervention or surgery have pre-operative NNNS assessment as PCH as standard of care. The NNNS takes approximately 30 minutes to complete. It is administered by a licensed physical, speech, or occupational therapist who has completed training and additional certification. The NNNS therapist will be blinded to the results of the fetal echocardiogram and MCA-PI.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Whitnee Hogan, MD","CONTACT","801-213-3599","whitnee.hogan@hsc.utah.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Lisa M. Hansen, BA","801-587-9104","lisa.hansen@hsc.utah.edu",[36,57,71,86,96],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of California San Francisco","NOT_YET_RECRUITING","San Francisco","California","94143","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.41942,37.77493,{"lat":48,"lon":47},[51,54],{"name":52,"role":28,"phone":20,"phoneExt":20,"email":53},"Disha Goel","disha.goel@ucsf.edu",{"name":55,"role":28,"phone":20,"phoneExt":20,"email":56},"Shabnam Peyvandi, MD","shabnam.peyvandi@ucsf.edu",{"facility":58,"status":38,"city":59,"state":60,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"type":45,"coordinates":63},[64,65],-77.03637,38.89511,{"lat":65,"lon":64},[68],{"name":69,"role":28,"phone":20,"phoneExt":20,"email":70},"Jennifer Klein, MD","JKlein@childrensnational.org",{"facility":72,"status":38,"city":73,"state":74,"zip":75,"country":42,"countryCode":43,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Maine Medical Center","Scarborough","Maine","04074",{"type":45,"coordinates":77},[78,79],-70.32172,43.57814,{"lat":79,"lon":78},[82],{"name":83,"role":28,"phone":84,"phoneExt":20,"email":85},"Thomas Miller, DO","207-883-5532","Thomas.A.Miller@mainehealth.org",{"facility":87,"status":38,"city":88,"state":89,"zip":90,"country":42,"countryCode":43,"cosmosGeoPoint":91,"geoPoint":95,"contacts":20},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":45,"coordinates":92},[93,94],-111.89105,40.76078,{"lat":94,"lon":93},{"facility":5,"status":97,"city":88,"state":89,"zip":98,"country":42,"countryCode":43,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"RECRUITING","84132",{"type":45,"coordinates":100},[93,94],{"lat":94,"lon":93},[103,105],{"name":104,"role":28,"phone":33,"phoneExt":20,"email":34},"Lisa M Hansen, BA",{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":107,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Whitnee Hogan, MD (Assistant Professor)","M.D., Assistant Professor",[111,112],{"name":87,"class":6},{"name":113,"class":114},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100498217","phase-2-fetal-cerebrovascular-autoregulation-in-congenital-heart-disease-and-association-with-neonatal-neurobehavior-100498217",false,"NCT05767385","Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior","Inclusion Criteria:\n\n* Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth.\n\nExclusion Criteria:\n\n* Known fetal chromosomal or genetic abnormalities\n* Multiple gestation pregnancy\n* Fetal extra-cardiac anomalies","FEMALE","0 Years","52 Years",{"count":125,"type":126},150,"ESTIMATED","INTERVENTIONAL",[129,130],"PHASE2","PHASE3","Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design.\n\nPregnant women will be approached during one of their fetal cardiology clinic visits.",[133,134,135,136],"Congenital Heart Disease in Children","Hypoxia","Neurodevelopmental Disorders","Complex Congenital Heart Disease",[138,139,140],"Congenital Heart Disease","Maternal Fetal","Neonatal Neurodevelopment","2025-06-18",{"date":143,"type":144},"2025-06-25","ACTUAL",{"date":146,"type":144},"2021-12-17",{"date":148,"type":126},"2025-12",{"name":5,"class":6},5]