[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06434207":3,"trial-entities:NCT06434207":81,"trial-summary:NCT06434207":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":48,"locations":50,"central_contacts":72,"overall_officials":78,"references":79,"see_also_links":80},"NCT06434207","IRB-P00048093","Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis","RECRUITING","2026-12-01","2025-09","2026-02-23","2024-10-31","Boston Children's Hospital","OTHER",false,"Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.\n\nThe goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.",null,[18,19,20],"Congenital Heart Disease","Single-ventricle","Thrombosis",[],"OBSERVATIONAL",[],{"count":25,"type":26},10,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Collecting discarded blood samples","Discarded blood samples will be collected from routine clinical labs collected before and after surgery.",[32],"Neonates with Congenital Heart Disease",[34],{"measure":35,"description":36,"timeFrame":37},"Characterization of microRNA in whole blood samples from neonates","isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways","2 days",[],"ALL","1 Day","7 Days",{"inclusion":43,"exclusion":45,"raw_text":47},[44],"All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life",[46],"None","Inclusion Criteria:\n\n* All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life\n\nExclusion Criteria:\n\n* None",[49],"CHILD",[51],{"facility":12,"status":7,"city":52,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":69},"Boston","Massachusetts","02115","United States",[57,62,66],{"name":58,"role":59,"phone":60,"email":61},"Jocelyn Booth, BSN","CONTACT","857-218-4585","jocelyn.booth@childrens.harvard.edu",{"name":63,"role":59,"phone":64,"email":65},"Rachel Bernier, MPH","18572185348","rachel.bernier@childrens.harvard.edu",{"name":67,"role":68},"Koichi Yuki, MD","PRINCIPAL_INVESTIGATOR",{"lat":70,"lon":71},42.35843,-71.05977,[73,75],{"name":63,"role":59,"phone":74,"email":65},"857-218-5348",{"name":76,"role":59,"email":77},"Hanna Van Pelt, BS","hanna.vanpelt@childrens.harvard.edu",[],[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[18],[],{"nct_id":4,"found":85,"summary":86,"prompt_version":96},true,{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an observational study involving 10 neonates. It is not a treatment study but rather focuses on understanding a medical condition.","completed","Understanding Blood Clot Risk in Newborns with Congenital Heart Disease","This observational study aims to understand why newborns with severe congenital heart disease (CHD) are at higher risk for blood clots after heart surgery. Researchers will collect discarded blood samples from ten neonates (newborns) at Boston Children's Hospital who are undergoing surgery in their first week of life. The goal is to characterize microRNA (tiny molecules that help control gene activity) in these blood samples to learn more about the molecular mechanisms that lead to abnormal clotting. This study is for newborns aged 1 to 7 days with severe CHD who are having surgery, and there are no exclusion criteria. The main goal is to understand the microRNA profile in these blood samples within two days of collection.","MicroRNA will be measured in blood samples at 2 days after collection.",118,"Participation involves collecting discarded blood samples from routine clinical labs before and after surgery. No additional procedures are required.","Not stated in the trial record.",[],"v2"]