[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054167":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":56,"studyPopulation":46,"armGroups":57,"interventions":68,"overallOfficials":46,"centralContacts":76,"locations":82,"responsibleParty":242,"collaborators":245,"id":270,"slug":46,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":271,"sex":277,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":46,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":290,"overallStatus":163,"whyStopped":46,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"Nemours Children's Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"In-hospital mortality","Death of a baby during birth hospitalization","From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks",[14,18,22,25,28,31,34,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Hemoglobin at or after 24 hours","Hb levels","Days 1-7",{"measure":19,"description":20,"timeFrame":21},"Early and late onset culture positive sepsis","Number of infants with early onset or late onset sepsis","From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.",{"measure":23,"description":24,"timeFrame":21},"Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)","Number of infants with any IVH or severe IVH",{"measure":26,"description":27,"timeFrame":21},"Need for blood transfusion","Number of infants received blood transfusion",{"measure":29,"description":30,"timeFrame":21},"Moderate to severe hypoxemic ischemic encephalopathy","Number of infants with moderate to severe hypoxemic ischemic encephalopathy",{"measure":32,"description":33,"timeFrame":21},"Necrotizing enterocolitis (Bell's stage 2 or higher)","Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher)",{"measure":35,"description":36,"timeFrame":21},"Need for medications for hypotension","Number of infants needed medications for hypotension",{"measure":38,"description":39,"timeFrame":21},"Need for phototherapy for jaundice","Number of infants needed phototherapy for jaundice",{"measure":41,"description":42,"timeFrame":21},"Retinopathy of prematurity (ROP) requiring intervention","Number of infants with ROP that required intervention",{"measure":44,"description":45,"timeFrame":21},"Length of hospitalization","Number of days infants stayed in hospital",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":46,"timePerspective":46,"maskingInfo":52},"RANDOMIZED","CROSSOVER","Cluster Randomized Crossover","PREVENTION",{"masking":53,"maskingDescription":46,"whoMasked":54},"SINGLE",[55],"OUTCOMES_ASSESSOR","Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.\n\nDelayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.\n\nHYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.\n\nMETHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.\n\nIMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Umbilical Cord Milking","ACTIVE_COMPARATOR","The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C\u002FS and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC).",[63],"Procedure: Umbilical cord milking",{"label":65,"type":66,"description":67,"interventionNames":46},"Early Cord Clamping","NO_INTERVENTION","Umbilical cord will be clamped immediately after birth (within 60 seconds)",[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"PROCEDURE","Umbilical cord milking","At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.",[59],[75],"UCM",[77],{"name":78,"role":79,"phone":80,"phoneExt":46,"email":81},"Zubair H Aghai, MD","CONTACT","215 955 6523","zaghai@nemours.org",[83,105,123,139,161,177,194,211,229],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College","NOT_YET_RECRUITING","Belagavi","Karnataka","590010","India","IN",{"type":92,"coordinates":93},"Point",[94,95],74.50447,15.85212,{"lat":95,"lon":94},[98,102],{"name":99,"role":79,"phone":100,"phoneExt":46,"email":101},"Sangappa Dhaded, MD","+91 98442 32586","drdhadedsm@gmail.com",{"name":103,"role":104,"phone":46,"phoneExt":46,"email":46},"Shivaprasad Goudar, MD","SUB_INVESTIGATOR",{"facility":106,"status":85,"city":107,"state":108,"zip":109,"country":89,"countryCode":90,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Government Medical College","Chandrapur","Maharashtra","442401",{"type":92,"coordinates":111},[112,113],79.29523,19.95076,{"lat":113,"lon":112},[116,119,121],{"name":117,"role":79,"phone":46,"phoneExt":46,"email":118},"Milind Kamble, MD","mkamble1732@ymail.com",{"name":117,"role":120,"phone":46,"phoneExt":46,"email":46},"PRINCIPAL_INVESTIGATOR",{"name":122,"role":120,"phone":46,"phoneExt":46,"email":46},"Deepti Shrirame, MD",{"facility":124,"status":85,"city":125,"state":108,"zip":126,"country":89,"countryCode":90,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Indira Gandhi Government Medical College & Hospital","Nagpur","440018",{"type":92,"coordinates":128},[129,130],79.08491,21.14631,{"lat":130,"lon":129},[133,136,138],{"name":134,"role":79,"phone":46,"phoneExt":46,"email":135},"Alka Patankar, MD","alkajatkar@gmail.com",{"name":137,"role":120,"phone":46,"phoneExt":46,"email":46},"Milind Suryavanshi, MD",{"name":134,"role":120,"phone":46,"phoneExt":46,"email":46},{"facility":140,"status":85,"city":141,"state":108,"zip":142,"country":89,"countryCode":90,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Yashwantrao Chavan Memorial Hospital","Pune","411018",{"type":92,"coordinates":144},[145,146],73.85535,18.51957,{"lat":146,"lon":145},[149,152,153,155,157,159],{"name":150,"role":79,"phone":46,"phoneExt":46,"email":151},"Mahesh Asalkar, MD","mahesh@asalkarclinic.com",{"name":150,"role":120,"phone":46,"phoneExt":46,"email":46},{"name":154,"role":120,"phone":46,"phoneExt":46,"email":46},"Deepali Ambike, MD",{"name":156,"role":104,"phone":46,"phoneExt":46,"email":46},"Rajesh Kulkarni, MD",{"name":158,"role":104,"phone":46,"phoneExt":46,"email":46},"Hemraj Narkheded, MD",{"name":160,"role":104,"phone":46,"phoneExt":46,"email":46},"Sandhya Haribhakta, MD",{"facility":162,"status":163,"city":125,"state":164,"zip":165,"country":89,"countryCode":90,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"Daga Memorial Woman and Children Hospital","RECRUITING","MS","440002",{"type":92,"coordinates":167},[129,130],{"lat":130,"lon":129},[170,174,176],{"name":171,"role":79,"phone":172,"phoneExt":46,"email":173},"Seema Parvekar, MD","+91-98909 87153","seemaparvekar@gmail.com",{"name":175,"role":120,"phone":46,"phoneExt":46,"email":46},"Vineeta Jain, MD",{"name":171,"role":120,"phone":46,"phoneExt":46,"email":46},{"facility":178,"status":85,"city":125,"state":164,"zip":179,"country":89,"countryCode":90,"cosmosGeoPoint":180,"geoPoint":182,"contacts":183},"Government Medical College and Hospital","440009",{"type":92,"coordinates":181},[129,130],{"lat":130,"lon":129},[184,188,190,192],{"name":185,"role":79,"phone":186,"phoneExt":46,"email":187},"Manish Tiwari, MD","+91 9552526538","manishtiwari.peds@rediffmail.com",{"name":189,"role":120,"phone":46,"phoneExt":46,"email":46},"Manoj Bhatnagar, MD",{"name":191,"role":120,"phone":46,"phoneExt":46,"email":46},"Manjushri Waikar, MD",{"name":193,"role":104,"phone":46,"phoneExt":46,"email":46},"Nidhi Nashine",{"facility":195,"status":85,"city":196,"state":164,"zip":197,"country":89,"countryCode":90,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Mahatma Gandhi Institute of Medical Sciences\u002F Kasturba Hospital","Wardha","442102",{"type":92,"coordinates":199},[200,201],78.59784,20.73933,{"lat":201,"lon":200},[204,208,209],{"name":205,"role":79,"phone":206,"phoneExt":46,"email":207},"Manish Jain, MD","+91-98226 95195","manish@mgims.ac.in",{"name":205,"role":120,"phone":46,"phoneExt":46,"email":46},{"name":210,"role":120,"phone":46,"phoneExt":46,"email":46},"Shuchi Jain, MD",{"facility":212,"status":163,"city":213,"state":214,"zip":215,"country":89,"countryCode":90,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Sawai Man Singh Medical College","Jaipur","Rajasthan","302004",{"type":92,"coordinates":217},[218,219],75.78781,26.91962,{"lat":219,"lon":218},[222,224,225,227],{"name":223,"role":79,"phone":46,"phoneExt":46,"email":46},"Seema Mehta, MD",{"name":223,"role":120,"phone":46,"phoneExt":46,"email":46},{"name":226,"role":120,"phone":46,"phoneExt":46,"email":46},"Asha Varma, MD",{"name":228,"role":120,"phone":46,"phoneExt":46,"email":46},"Sunil Gothwal, MD",{"facility":230,"status":163,"city":231,"state":232,"zip":233,"country":89,"countryCode":90,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Osmania Medical College, Niloufer Hospital","Hyderabad","Telangana","500004",{"type":92,"coordinates":235},[236,237],78.45636,17.38405,{"lat":237,"lon":236},[240],{"name":241,"role":79,"phone":46,"phoneExt":46,"email":46},"D Suchitra, MD",{"type":120,"investigatorFullName":243,"investigatorTitle":244,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Zubair Aghai","Professor of Pediatrics",[246,248,250,252,254,257,259,261,263,266,268],{"name":247,"class":6},"Thrasher Research Fund",{"name":249,"class":6},"Thomas Jefferson University",{"name":251,"class":6},"Sharp HealthCare",{"name":253,"class":6},"Jawaharlal Nehru Medical College",{"name":255,"class":256},"Daga Memorial Maternity and Children's Hospital, Nagpur, India","UNKNOWN",{"name":258,"class":6},"Mahatma Gandhi Institute of Medical Sciences",{"name":260,"class":256},"Indira Gandhi Government Medical College & Hospital, Nagpur, India",{"name":262,"class":256},"Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India",{"name":264,"class":265},"Government Medical College, Nagpur","INDUSTRY",{"name":267,"class":256},"Government Medical College, Chandrapur, India",{"name":269,"class":256},"Osmania Medical College, Niloufer Hospital, Hyderabad, India","100054167",false,"NCT06240715","Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm","A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth","CORDMILK-PT","Inclusion Criteria:\n\n* Preterm infants born between 30 0\u002F7 weeks to 34 6\u002F7 weeks of gestation\n* Non-vigorous at birth\n\nExclusion Criteria:\n\n* Infants with congenital malformation\n* Major chromosomal abnormalities\n* Complete placental abruption\u002Fcutting through the placenta at the time of delivery\n* Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)\n* Mono-chorionic twins,\n* Twins with no information on amnion\u002Fchorion\n* Multiple gestation \\>2","ALL","0 Minutes","10 Minutes",{"count":281,"type":282},800,"ESTIMATED","INTERVENTIONAL",[285],"NA","The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.",[288,289],"Preterm","Infant Death",[288,71,291],"Placental transfusion","2026-07-09",{"date":294,"type":295},"2026-07-13","ACTUAL",{"date":297,"type":295},"2024-07-01",{"date":299,"type":282},"2027-03-30",{"name":5,"class":6},9]