[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527876":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":56,"locations":65,"responsibleParty":364,"collaborators":367,"id":388,"slug":389,"hasResults":390,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":390,"sex":396,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":38,"studyType":402,"phases":403,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":68,"whyStopped":38,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed Cord Clamping at 30 Seconds (DCC-30)","ACTIVE_COMPARATOR","The umbilical cord will be clamped between 1 - \\\u003C60 seconds following delivery, with a goal of around 30 seconds.",[13],"Procedure: Umbilical Cord Clamping at ~30 seconds",{"label":15,"type":10,"description":16,"interventionNames":17},"Delayed Cord Clamping at 120 Seconds (DCC-120)","The umbilical cord will be clamped at 60 - 180- seconds following delivery, with a goal of around 120 seconds.\n\nIn the DCC-120 group, if there is concern for pregnant individual or baby and their doctor is not able to wait until at least 60 seconds, the doctor may do cord milking, which is four gentle squeezes of the umbilical cord pushing blood from the placenta to baby.",[18,19],"Procedure: Umbilical Cord Clamping at ~120 seconds","Procedure: Umbilical Cord Milking",[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Umbilical Cord Clamping at ~30 seconds","Care team will wait to clamp the umbilical between 1-\\\u003C60 seconds after birth. 30 seconds is the ideal time of clamping.",[9],[27],"Randomized to DCC-30 Group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Umbilical Cord Clamping at ~120 seconds","Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping",[15],[33],"Randomized to DCC-120 Group",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Umbilical Cord Milking","For infants who need their cord clamped before the target in the DCC-120 group. Care team may milk the umbilical cord towards the infant four times. Cord milking should NOT be performed if the delay meets or exceeds 60 seconds.\n\nUmbilical cord milking will not be provided among participant-infant dyads in the DCC-30 group.",[15],null,[40,43,46,49,52,54],{"name":41,"affiliation":5,"role":42},"Carl Backes, MD","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":42},"Anup Katheria, MD","Sharp Mary Birch Hospital for Women & Newborns",{"name":47,"affiliation":48,"role":42},"Kevin Hill, MD","Duke Children's Hospital",{"name":50,"affiliation":51,"role":42},"Madeline Rice, PhD","George Washington University Biostatistics Center",{"name":53,"affiliation":51,"role":42},"Grecio (Greg) Sandoval, PhD",{"name":55,"affiliation":51,"role":42},"Scott Evans, PhD",[57,61],{"name":41,"role":58,"phone":59,"phoneExt":38,"email":60},"CONTACT","614-355-6729","carl.backes@nationwidechildrens.org",{"name":62,"role":58,"phone":63,"phoneExt":38,"email":64},"Chelsea E Cobe, BA","614-355-6651","chelsea.cobe@nationwidechildrens.org",[66,84,98,112,125,142,156,170,184,198,211,226,240,254,268,282,296,309,323,338,351],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Children's of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-86.80249,33.52066,{"lat":78,"lon":77},[81],{"name":82,"role":58,"phone":38,"phoneExt":38,"email":83},"Andrea Kane, MD","akane@uabmc.edu",{"facility":85,"status":68,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Cedars-Sinai Medical Center","Los Angeles","California","90048",{"type":75,"coordinates":90},[91,92],-118.24368,34.05223,{"lat":92,"lon":91},[95],{"name":96,"role":58,"phone":38,"phoneExt":38,"email":97},"Ruchira Garg, MD","ruchira.garg@cshs.org",{"facility":99,"status":100,"city":101,"state":87,"zip":102,"country":72,"countryCode":73,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Children's Hospital of Orange County","NOT_YET_RECRUITING","Orange","92868",{"type":75,"coordinates":104},[105,106],-117.85311,33.78779,{"lat":106,"lon":105},[109],{"name":110,"role":58,"phone":38,"phoneExt":38,"email":111},"Shawn Sen, MD","shawn.sen@choc.org",{"facility":113,"status":100,"city":114,"state":87,"zip":115,"country":72,"countryCode":73,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Lucile Packard Children's Hospital Stanford","Palo Alto","94304",{"type":75,"coordinates":117},[118,119],-122.14302,37.44188,{"lat":119,"lon":118},[122],{"name":123,"role":58,"phone":38,"phoneExt":38,"email":124},"Alexis Davis, MD","asdavis@stanford.edu",{"facility":126,"status":68,"city":127,"state":87,"zip":128,"country":72,"countryCode":73,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Sharp Mary Birch Hospital for Woman and Newborns","San Diego","92123",{"type":75,"coordinates":130},[131,132],-117.16472,32.71571,{"lat":132,"lon":131},[135,137,140,141],{"name":44,"role":58,"phone":38,"phoneExt":38,"email":136},"anup.katheria@sharp.com",{"name":138,"role":58,"phone":38,"phoneExt":38,"email":139},"Jenny Koo, MD","Jenny.Koo@sharp.com",{"name":44,"role":42,"phone":38,"phoneExt":38,"email":38},{"name":138,"role":42,"phone":38,"phoneExt":38,"email":38},{"facility":143,"status":68,"city":144,"state":145,"zip":146,"country":72,"countryCode":73,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"UF Health Shands Children's Hospital","Gainesville","Florida","32608",{"type":75,"coordinates":148},[149,150],-82.32483,29.65163,{"lat":150,"lon":149},[153],{"name":154,"role":58,"phone":38,"phoneExt":38,"email":155},"Jennifer Co-Vu, MD","jcovu@mail.ufl.edu",{"facility":157,"status":68,"city":158,"state":159,"zip":160,"country":72,"countryCode":73,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Johns Hopkins Children's Center","Baltimore","Maryland","21287",{"type":75,"coordinates":162},[163,164],-76.61219,39.29038,{"lat":164,"lon":163},[167],{"name":168,"role":58,"phone":38,"phoneExt":38,"email":169},"Victoria Surma, MD","vsurma1@jhmi.edu",{"facility":171,"status":68,"city":172,"state":173,"zip":174,"country":72,"countryCode":73,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Children's of Mississippi","Jackson","Mississippi","39216",{"type":75,"coordinates":176},[177,178],-90.18481,32.29876,{"lat":178,"lon":177},[181],{"name":182,"role":58,"phone":38,"phoneExt":38,"email":183},"Simon Karam, MD","skaram@umc.edu",{"facility":185,"status":68,"city":186,"state":187,"zip":188,"country":72,"countryCode":73,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":75,"coordinates":190},[191,192],-94.57857,39.09973,{"lat":192,"lon":191},[195],{"name":196,"role":58,"phone":38,"phoneExt":38,"email":197},"John Daniel, MD","jmdaniel@cmh.edu",{"facility":199,"status":68,"city":200,"state":187,"zip":201,"country":72,"countryCode":73,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"SSM Health Cardinal Glennon Children's Hospital","St Louis","63104",{"type":75,"coordinates":203},[204,205],-90.19789,38.62727,{"lat":205,"lon":204},[208],{"name":209,"role":58,"phone":38,"phoneExt":38,"email":210},"Justin Josephsen, MD","justin.josephsen@health.slu.edu",{"facility":212,"status":68,"city":213,"state":214,"zip":215,"country":72,"countryCode":73,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Duke Children's Hospital & Health Center","Durham","North Carolina","27705",{"type":75,"coordinates":217},[218,219],-78.89862,35.99403,{"lat":219,"lon":218},[222,225],{"name":223,"role":58,"phone":38,"phoneExt":38,"email":224},"Kevin Hill","kevin.hill@duke.edu",{"name":47,"role":42,"phone":38,"phoneExt":38,"email":38},{"facility":5,"status":68,"city":227,"state":228,"zip":229,"country":72,"countryCode":73,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Columbus","Ohio","43205",{"type":75,"coordinates":231},[232,233],-82.99879,39.96118,{"lat":233,"lon":232},[236],{"name":237,"role":58,"phone":238,"phoneExt":38,"email":239},"Carl H. Backes, MD","6142646374","Carl.Backes@nationwidechildrens.org",{"facility":241,"status":68,"city":242,"state":243,"zip":244,"country":72,"countryCode":73,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":75,"coordinates":246},[247,248],-75.16362,39.95238,{"lat":248,"lon":247},[251],{"name":252,"role":58,"phone":38,"phoneExt":38,"email":253},"Elizabeth Foglia, MD","foglia@chop.edu",{"facility":255,"status":68,"city":256,"state":257,"zip":258,"country":72,"countryCode":73,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Medical University of South Carolina","Columbia","South Carolina","29209",{"type":75,"coordinates":260},[261,262],-81.03481,34.00071,{"lat":262,"lon":261},[265],{"name":266,"role":58,"phone":38,"phoneExt":38,"email":267},"Sinai Zyblewski, MD","chois@musc.edu",{"facility":269,"status":68,"city":270,"state":271,"zip":272,"country":72,"countryCode":73,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Monroe Carell Jr. Children's Hospital at Vanderbilt","Nashville","Tennessee","37232",{"type":75,"coordinates":274},[275,276],-86.78444,36.16589,{"lat":276,"lon":275},[279],{"name":280,"role":58,"phone":38,"phoneExt":38,"email":281},"Prince Kannankeril, MD","prince.kannankeril@vumc.org",{"facility":283,"status":68,"city":284,"state":285,"zip":286,"country":72,"countryCode":73,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Texas Children's Hospital","Houston","Texas","77030",{"type":75,"coordinates":288},[289,290],-95.36327,29.76328,{"lat":290,"lon":289},[293],{"name":294,"role":58,"phone":38,"phoneExt":38,"email":295},"Nathan Sundgren, MD, PhD","ncsundgr@texaschildrens.org",{"facility":297,"status":68,"city":298,"state":285,"zip":299,"country":72,"countryCode":73,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"University of Texas Health Science Center at San Antonio","San Antonio","78229",{"type":75,"coordinates":301},[302,303],-98.49363,29.42412,{"lat":303,"lon":302},[306],{"name":307,"role":58,"phone":38,"phoneExt":38,"email":308},"J.B. Cantey, MD","cantey@uthsca.edu",{"facility":310,"status":68,"city":311,"state":312,"zip":313,"country":72,"countryCode":73,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":75,"coordinates":315},[316,317],-111.89105,40.76078,{"lat":317,"lon":316},[320],{"name":321,"role":58,"phone":38,"phoneExt":38,"email":322},"Ryan Carpenter, MD","ryan.carpenter@hsc.utah.edu",{"facility":324,"status":68,"city":325,"state":326,"zip":38,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Stollery Children's Hospital, University of Alberta","Edmonton","Alberta","Canada","CA",{"type":75,"coordinates":330},[331,332],-113.46871,53.55014,{"lat":332,"lon":331},[335],{"name":336,"role":58,"phone":38,"phoneExt":38,"email":337},"Brenda Law, MD","blaw2@ualberta.ca",{"facility":339,"status":68,"city":340,"state":341,"zip":38,"country":327,"countryCode":328,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"IWK Health Centre","Halifax","Nova Scotia",{"type":75,"coordinates":343},[344,345],-63.57688,44.64269,{"lat":345,"lon":344},[348],{"name":349,"role":58,"phone":38,"phoneExt":38,"email":350},"Walid El-Naggar, MD","walid.el-naggar@iwk.nshealth.ca",{"facility":352,"status":100,"city":353,"state":354,"zip":38,"country":327,"countryCode":328,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"The Hospital for Sick Children","Toronto","Ontario",{"type":75,"coordinates":356},[357,358],-79.39864,43.70643,{"lat":358,"lon":357},[361],{"name":362,"role":58,"phone":38,"phoneExt":38,"email":363},"Michael Seed, MBBS","mike.seed@sickkids.ca",{"type":365,"investigatorFullName":41,"investigatorTitle":366,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Principal Investigator",[368,370,373,375,377,379,382,384,385,386],{"name":369,"class":6},"The George Washington University Biostatistics Center",{"name":371,"class":372},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":374,"class":6},"Emory University",{"name":376,"class":6},"Boston Children's Hospital",{"name":378,"class":6},"University of Bristol",{"name":380,"class":381},"Geisinger Commonwealth School of Medicine","UNKNOWN",{"name":383,"class":6},"Duke University",{"name":241,"class":6},{"name":45,"class":6},{"name":387,"class":6},"Université de Montréal","100527876","cord-clamping-among-neonates-with-congenital-heart-disease-100527876",false,"NCT06153459","Cord Clamping Among Neonates With Congenital Heart Disease","CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease","CORD-CHD","Inclusion criteria are listed below and will be confirmed prior to randomization:\n\n1. Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound \u002F echocardiography from local fetal ECHO, conducted on or after 18 weeks of gestation and prior to randomization. The study fetal diagnosis of CHD must be rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), as determined by independent evaluators at the CORD-CHD trial ECHO Core at the Children's Hospital of Philadelphia (to determine final FCDSS eligibility for randomization).\n\n   For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 weeks of gestation and randomization for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.\\]\n\n   \\[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\\]\n2. Singleton gestation.\n3. Gestational age at randomization for impending deliveries between 37 0\u002F7 - 41 6\u002F7 weeks of gestation inclusive based on clinical information and evaluation of the earliest ultrasound determined using criteria proposed by the American Congress of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine.\n\n   \\[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0\u002F7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0\u002F7 and 41 6\u002F7 weeks \"eligibility window\". Alternatively, if an eligible dyad is randomized at or just prior to 41 6\u002F7 weeks, they remain in trial.\\]\n4. Consent for the participant and their infant\n\nExclusion criteria are listed below and will be confirmed prior to randomization:\n\nExclusion Criteria for Pregnant Individuals:\n\n1. Pregnant individual is a gestational carrier or surrogate.\n2. Compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension, placental abruption, amniotic fluid embolism, uterine rupture, uterine inversion, disseminated intravascular coagulation), as determined by local care team\n\n\\[NOTE: There is no limitation on pregnant individual's age\\]\n\nFetal Exclusion Criteria:\n\n1. Fetal demise or planned termination of pregnancy prior to randomization\n2. Tachyarrhythmia requiring transplacental therapy\n3. Fetal hydrops, severe\n4. Planned fetal surgery\n5. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia\n6. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed\n7. Disease or disorder impacting candidacy for neonatal cardiac interventions\n8. Parents choosing to limit treatment\n\nPregnancy Exclusion Criteria:\n\n1. Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site\n2. Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality","ALL","37 Weeks","42 Weeks",{"count":400,"type":401},500,"ESTIMATED","INTERVENTIONAL",[404],"NA","The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are:\n\n* Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes?\n* Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)?\n\nParticipants will be asked to do the following:\n\n* Participate in either DCC-120 or DCC-30 at birth (randomized assignment).\n* Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires \u002F surveys at this time.\n* Complete questionnaires \u002F surveys at 9-12 months of infant age (postnatal).\n* Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires \u002F surveys at 22-26 months of infant age (postnatal).\n* Permit data collection from electronic medical records for both the mother and infant study participants.\n\nInvestigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.",[407],"Congenital Heart Disease (CHD)",[409,410,411,394],"cord clamping","echocardiography (ECHO)","congenital heart disease (CHD)","2025-07-31",{"date":414,"type":415},"2025-08-05","ACTUAL",{"date":417,"type":415},"2023-12-19",{"date":419,"type":401},"2030-12",{"name":41,"class":6},21]