[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647222":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":94,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric Cardiac Surgery and Pediatric Catheterization Patients",null,"This cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated.\n\nAs part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure.\n\nArterial blood samples obtained for clinical care will be analyzed using standard blood-gas\u002Fco-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis.\n\nThis is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis.",[13],"Device: Noninvasive hemoglobin monitoring",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Noninvasive hemoglobin monitoring","This study evaluates noninvasive hemoglobin monitoring using a near-infrared spectroscopy (NIRS)-based tissue oximetry system in pediatric patients undergoing cardiac surgery or cardiac catheterization under general anesthesia.\n\nA FDA-cleared ForeSight Tissue Oximetry sensor is placed on the forehead to continuously measure tissue oxygenation, and an algorithm is derived to estimate hemoglobin.\n\nReference hemoglobin values are obtained from arterial blood samples analyzed using standard blood-gas\u002Fco-oximetry methods as part of routine clinical care. A small number of additional samples may be collected if needed.\n\nThe study compares noninvasive hemoglobin estimates with laboratory hemoglobin measurements. No investigational devices are used, and there is no change to clinical care.",[9],[21],{"name":22,"affiliation":5,"role":23},"Dima Daaboul","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Dima Daaboul, MD","CONTACT","(617) 355-1370","dima.daaboul@childrens.harvard.edu",{"name":31,"role":27,"phone":28,"phoneExt":10,"email":32},"Barry Kussman, MBBCh, FFA(SA)","Barry.Kussman@childrens.harvard.edu",[34],{"facility":5,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Boston","Massachusetts","02115","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-71.05977,42.35843,{"lat":44,"lon":43},[47,51,55,56],{"name":48,"role":27,"phone":49,"phoneExt":10,"email":50},"Rachel Bernier, MPH","857-218-5348","rachel.bernier@childrens.harvard.edu",{"name":52,"role":27,"phone":53,"phoneExt":10,"email":54},"Jocelyn Booth, BSN","857-218-4585","jocelyn.booth@childrens.harvard.edu",{"name":26,"role":23,"phone":10,"phoneExt":10,"email":10},{"name":31,"role":57,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":23,"investigatorFullName":22,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Cardiac Anesthesiologist",[61],{"name":62,"class":63},"Becton, Dickinson and Company","INDUSTRY","100647222","observational-data-collection-for-blood-hemoglobin-algorithm-validation-in-pediatrics-100647222",false,"NCT07706140","Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics","Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization","Inclusion Criteria:\n\n1. Age less than 21 years at the time of enrollment.\n2. Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.\n3. Placement of an arterial catheter as part of routine clinical care for the procedure.\n\nExclusion Criteria:\n\n1. Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.\n2. Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.","ALL","0 Days","21 Years",{"count":75,"type":76},100,"ESTIMATED","OBSERVATIONAL","This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care.\n\nThe goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.",[80,81,82],"Hemoglobin","Cerebral Oxygenation","Congenital Heart Disease",[84,85,86,87,88,89,90,91,92,93],"pediatric cardiac surgery","pediatric cardiac catheterization","transfusion guidance","noninvasive hemoglobin monitoring","near-infrared spectroscopy NIRS monitoring","tissue oximetry","ForeSight system","HemoSphere monitor","algorithm validation","arterial blood gas comparison","NOT_YET_RECRUITING","2026-07-24",{"date":97,"type":98},"2026-07-27","ACTUAL",{"date":100,"type":76},"2026-08",{"date":102,"type":76},"2027-12",{"name":5,"class":6},1]