[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547469":3},{"organization":4,"outcomesModule":7,"designInfo":200,"detailedDescription":209,"studyPopulation":203,"armGroups":210,"interventions":221,"overallOfficials":227,"centralContacts":231,"locations":240,"responsibleParty":257,"collaborators":203,"id":259,"slug":260,"hasResults":261,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":203,"eligibilityCriteria":264,"healthyVolunteers":261,"sex":265,"minAge":203,"maxAge":203,"enrollmentInfo":266,"targetDuration":203,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":203,"overallStatus":243,"whyStopped":203,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},{"fullName":5,"class":6},"Hospital JP Garrahan","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":126},[9,13],{"measure":10,"description":11,"timeFrame":12},"Hemodynamic deterioration in the first 24 hours of life","Hemodynamic deterioration in the first 24 hours of life (meeting 3 of 4 of the following criteria or entry to extracorporeal membrane oxygenation (ECMO) or Death).\n\n1. Pre\u002Fpost ductal saturation difference \\>10%\n2. Oxygenation index (IO) \\>20\n3. mean arterial pressure \\\u003C Percentile 50 or inotrope requirement\n4. Lactic acid \\>3 mmol\u002Fl","24 hours of life",{"measure":14,"description":15,"timeFrame":16},"complete delivery according group","Complete the protocol in the delivery room pre-established according to randomization (yes\u002Fno)","delivery",[18,22,26,29,32,35,38,42,46,50,54,57,60,64,67,71,74,78,82,86,90,93,96,99,102,105,108,111,115,119,123],{"measure":19,"description":20,"timeFrame":21},"Gestational age at diagnosis","Gestational age at diagnosis of CDH in weeks","1st day of life",{"measure":23,"description":24,"timeFrame":25},"Lung heart rate index observed\u002Fexpected LHR O\u002FE","lung heart rate index observed\u002Fexpected (LHR O\u002FE)","from 26 to 32 weeks of gestational age",{"measure":27,"description":28,"timeFrame":25},"liver in thorax","liver in thorax (yes\u002Fno) and %",{"measure":30,"description":31,"timeFrame":25},"stomach herniation","stomach herniation (yes\u002Fno) and %",{"measure":33,"description":34,"timeFrame":25},"lung volumen","lung volumen in RMI",{"measure":36,"description":37,"timeFrame":25},"Mcgoon","Mcgoon Index in fetal echocardiogram",{"measure":39,"description":40,"timeFrame":41},"maternal hematocrit","maternal hematocrit in gr\u002Fdl","1 day before delivery",{"measure":43,"description":44,"timeFrame":45},"Intubation time","Time to intubation (minutes, seconds)","From delivery to intubation",{"measure":47,"description":48,"timeFrame":49},"Cord clamping time","Cord clamping time (minutes, seconds)","from delivery to cord clamping",{"measure":51,"description":52,"timeFrame":53},"Advance resuscitation need on delivery room","Requirement for advanced resuscitation (yes\u002Fno) (compressions, drugs, hypothermia)","from delivery to 30 minutes of life",{"measure":55,"description":56,"timeFrame":53},"Time to reach heart rate (HR) >100","Time to reach HR \\>100 (minutes, seconds)",{"measure":58,"description":59,"timeFrame":53},"Time to reach saturation (SAT) >85%","Time to reach SAT \\>85% (minutes, seconds)",{"measure":61,"description":62,"timeFrame":63},"Cord PH value","cord ph value","inmediatly after cord clampping",{"measure":65,"description":66,"timeFrame":63},"Cord lactic acid value","cord lactic acid value in mmol\u002Fl",{"measure":68,"description":69,"timeFrame":70},"saturation at 10 minutes","pre and post ductal saturation %","10 minutes of life",{"measure":72,"description":73,"timeFrame":70},"Arterial pressure at 10 minutes","mean arterial tension in mmhg",{"measure":75,"description":76,"timeFrame":77},"placenta abruption","Time for placental abruption (minutes, seconds)","30 minutes of life",{"measure":79,"description":80,"timeFrame":81},"Mother arterial tension after delivery","mothers arterial mean tension after delivery in mmhg","10 minutes after delivery",{"measure":83,"description":84,"timeFrame":85},"Uterotonic use","uterotonics use on mothers after delivery (yes\u002Fno)","30 minutes after delivery",{"measure":87,"description":88,"timeFrame":89},"Evolution of patient Blood preassure (BP)","Blood pressure in mmhg","2 - 4 hours and 24 hours of life",{"measure":91,"description":92,"timeFrame":89},"Evolution of patient inotropes required","Inotrope requirement (yes\u002Fno)",{"measure":94,"description":95,"timeFrame":89},"Inhaled nitric oxide (NOi) requirement","NOi requirement (yes\u002Fno)",{"measure":97,"description":98,"timeFrame":89},"ventilation requirements on the first day","Ventilatory mode \u002F mean airway pressure (MAP)\u002F FIo2 %",{"measure":100,"description":101,"timeFrame":89},"Oxygenation on the first day","Partial arterial pressure of oxygen (PaO2) mmhg",{"measure":103,"description":104,"timeFrame":89},"Oxygenation index (OI) on the first day","OI",{"measure":106,"description":107,"timeFrame":89},"near-infrared spectroscopy (Nirs) on the first day","Cerebral and somatic NIRS",{"measure":109,"description":110,"timeFrame":12},"B natriuretic peptide (BNP) on the first day","B natriuretic peptide (BNP)",{"measure":112,"description":113,"timeFrame":114},"PH value on the first day","echocardiographic pulmonary hypertension PH (\\\u003C50% of systemic pressure, between 50-80% of systemic pressure, between 80 and 100% of systemic pressure, systemic, suprasystemic)","6 and 24 hours of life",{"measure":116,"description":117,"timeFrame":118},"cardiac malformations","cardiac malformation (yes\u002Fno)","6 hours of life",{"measure":120,"description":121,"timeFrame":122},"Mortality","Mortality (yes\u002Fno)","through study completion, an average of 1 year",{"measure":124,"description":125,"timeFrame":122},"Admission to ECMO","Admission to ECMO after the first 24 hours (yes\u002Fno)",[127,130,133,136,139,142,145,148,151,154,157,160,163,166,169,172,175,178,181,185,188,191,194,197],{"measure":128,"description":129,"timeFrame":122},"maternal age","maternal age during pregnancy",{"measure":131,"description":132,"timeFrame":122},"maternal history","maternal pathological history during pregnancy (yes\u002Fno)",{"measure":134,"description":135,"timeFrame":77},"baby weight","Weight in grams",{"measure":137,"description":138,"timeFrame":114},"Patent ductus arteriosus (PAD) on the first day (size)","Patent ductus arteriosus (PAD): size in milimeters",{"measure":140,"description":141,"timeFrame":114},"Patent ductus arteriosus (PAD) on the first day (gradient)","Patent ductus arteriosus (PAD): gradient",{"measure":143,"description":144,"timeFrame":114},"Patent ductus arteriosus (PAD) on the first day (shunt direction)","Patent ductus arteriosus (PAD): shunt direction",{"measure":146,"description":147,"timeFrame":114},"Patent foramen ovale (PFO) on the first day (shunt direction)","Patent foramen ovale (PFO): shunt direction.",{"measure":149,"description":150,"timeFrame":114},"Right ventricle (RV) on the first day diameter","Right ventricle (RV): RV diameter in milimeters",{"measure":152,"description":153,"timeFrame":114},"Right ventricle (RV) on the first day TAPSE","Right ventricle (RV): TAPSE",{"measure":155,"description":156,"timeFrame":114},"Tricuspide Insufitienty","tricuspide insufitienty",{"measure":158,"description":159,"timeFrame":114},"Right ventricle funtion","Right ventricle global disfuntion : no, mild, moderate or severe",{"measure":161,"description":162,"timeFrame":114},"Left ventricle (LV) on the first day (eccentricity index)","Left ventricle (LV): eccentricity index",{"measure":164,"description":165,"timeFrame":114},"Left ventricle (LV) on the first day (ejection fraction)","Left ventricle (LV): ejection fraction (EF)",{"measure":167,"description":168,"timeFrame":114},"Left ventricle (LV) on the first day global funtion","Left ventricle (LV) global disfuntion : no, global disfuntion : no, mild, moderate or severe",{"measure":170,"description":171,"timeFrame":114},"Interventricular septum (IS) on the first day","Interventricular septum: configuration",{"measure":173,"description":174,"timeFrame":114},"Pulmonary hypertation grade on the first day","Pulmonary hypertation: no, mild, moderate or severe",{"measure":176,"description":177,"timeFrame":12},"Associated malformations","Associated malformations (yes\u002Fno), which",{"measure":179,"description":180,"timeFrame":122},"Chromosomopathy or genetic alteration","Chromosomopathy or genetic alteration (yes\u002Fno), which",{"measure":182,"description":183,"timeFrame":184},"Hyperbilirubinemia","Hyperbilirubinemia requiring phototherapy or exchange transfusion (yes\u002Fno)","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months",{"measure":186,"description":187,"timeFrame":184},"Early sepsis","Early sepsis (yes\u002Fno)",{"measure":189,"description":190,"timeFrame":184},"Omphalitis","Omphalitis (yes\u002Fno)",{"measure":192,"description":193,"timeFrame":184},"CDH surgery","CDH surgery (yes\u002Fno), days of life",{"measure":195,"description":196,"timeFrame":184},"Surgical classification","Surgical classification of CDH (a-b-c-d)",{"measure":198,"description":199,"timeFrame":184},"Days in neonatal intensive care unit (NICU)","Days in NICU",{"allocation":201,"interventionModel":202,"interventionModelDescription":203,"primaryPurpose":204,"observationalModel":203,"timePerspective":203,"maskingInfo":205},"RANDOMIZED","FACTORIAL",null,"PREVENTION",{"masking":206,"maskingDescription":203,"whoMasked":207},"SINGLE",[208],"PARTICIPANT","* Type of study: Randomized clinical trial\n* Primary objective: To establish the effectiveness of PFC in reducing hypoxia and improving cardiac output compared to immediate postintubation clamping in newborns with CDH. To establish the safety and feasibility of PFC after pulmonary recruitment achieved post intubation.\n* Secondary objectives: describe the evolution of patients with CDH 24 hours after birth under pre-established conditions. Relate prenatal indices to the subsequent evolution of these patients. Describe maternal evolution and postpartum complications.\n* Population: Patients who attend the Fetal Diagnosis and Treatment program of Garrahan Children's Hospital and undergo prenatal diagnosis of CDH are possible candidates. The study will be carried out in the Neonatal Intensive Care Unit of said hospital.\n* Scope of the study: Garrahan Children's Hospital is a level 3 B pediatric hospital and national referral center located in Autonomous City of Buenos Aires, Argentina. Center that receives neonates with CDH referred from all over the country as well as from other countries in the region and carries out the relevant training for equal reception.\n* Block randomization: will be carried out on the same day, 2 hours before entering the delivery room\n* Intervention: Immediately after birth, the newborn will be placed on a mobile table, made to received these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact, intubated and gently ventilated (positive inspiration pressure (PIM) 15\u002F25 - positive end expiratory pressure (PEEP)4 - fraction of inspired oxygen inspired oxygen fraction (FiO2) 50%), until saturation \\>85% and heart rate (HR) \\>100 or 10 timed minutes pass, whichever occurs first, the umbilical cord will be clamped and continued with the usual reception steps in accordance with the unit´s CDH reception protocol.\n* Sample size: To calculate the sample size, a prevalence of hemodynamic alterations of 60% was considered in the first 24 hours of life of patients with CDH, following unit statistics and the aforementioned bibliography. The estimated sample size with a relative reduction of 50%: reduction from 60% to 30% of hemodynamic alterations - Power of 80% - Two-tailed test - alpha 5%. 40 patients required in each branch.",[211,217],{"label":212,"type":213,"description":214,"interventionNames":215},"physiological umbilical cord clamping","EXPERIMENTAL","Immediately after birth, the newborn will be placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact and will be intubated. The patient will be gently ventilated (PIM 15\u002F25 - PEEP 4 - Fio2 50%), until saturation \\>85% and HR\\>100 or 10 timed minutes have elapsed, whichever occurs first, the umbilical cord will be clamped and the procedures continued usual reception steps according to the unit´s CDH reception protocol.",[216],"Procedure: Physiological cord clamping",{"label":218,"type":219,"description":220,"interventionNames":203},"usual reception","NO_INTERVENTION","Immediately after birth, the newborn is placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact will be intubated. According to the unit´s CDH reception protocol, patients with CDH cord clamping is done post intubation",[222],{"type":223,"name":224,"description":225,"armGroupLabels":226,"otherNames":203},"PROCEDURE","Physiological cord clamping","Immediately after birth, the newborn with prenatal diagnosis of CDH will be placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact and intubated. The patient will be gently ventilated (PIM 15\u002F25 - PEEP 4 - Fio2 50%), until saturation \\>85% and HR\\>100 or 10 timed minutes have elapsed, whichever occurs first, the umbilical cord will be clamped.",[212],[228],{"name":229,"affiliation":5,"role":230},"Mariela Jozefkowicz","PRINCIPAL_INVESTIGATOR",[232,236],{"name":229,"role":233,"phone":234,"phoneExt":203,"email":235},"CONTACT","+5491164646270","mjozefkowicz@garrahan.gov.ar",{"name":237,"role":233,"phone":238,"phoneExt":203,"email":239},"Maria T Mazzucchelli","+5491149170437","mtmazzu@gmail.com",[241],{"facility":242,"status":243,"city":244,"state":203,"zip":245,"country":246,"countryCode":247,"cosmosGeoPoint":248,"geoPoint":253,"contacts":254},"Hospital de Pediatría S.A.M.I.C. \"Prof. Dr. Juan P. Garrahan\"","RECRUITING","Buenos Aires","C1245AAM","Argentina","AR",{"type":249,"coordinates":250},"Point",[251,252],-58.37723,-34.61315,{"lat":252,"lon":251},[255,256],{"name":229,"role":233,"phone":234,"phoneExt":203,"email":235},{"name":237,"role":233,"phone":238,"phoneExt":203,"email":239},{"type":230,"investigatorFullName":229,"investigatorTitle":258,"investigatorAffiliation":5,"oldNameTitle":203,"oldOrganization":203},"Principal Investigator","100547469","physiological-umbilical-cord-clamping-in-patients-with-congenital-diaphragmatic-hernia-clinical-trial-100547469",false,"NCT06408376","Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial","Inclusion Criteria:\n\n* Prenatal diagnosis of congenital diaphragmatic hernia\n* gestational age \\>34 weeks\n* Informed consent signed by the patient's parents\n\nExclusion Criteria:\n\n* Multiple gestation\n* Major malformation or fetal genetic anomaly diagnosed in the prenatal stage\n* Emergency cesarean section or maternal condition that prevents the approach\n* Lack of informed consent","ALL",{"count":267,"type":268},80,"ESTIMATED","INTERVENTIONAL",[271],"NA","Congenital diaphragmatic hernia (CDH) is a malformation that affects 1 in every 3000 newborns. The diaphragm does not complete its closure during embryogenesis, which allows the abdominal organs to herniate into the thoracic cavity altering lung development. The lungs of patients with CDH are small, with a decreased surface area for gas exchange and developmental impair of the pulmonary vasculature, resulting in respiratory failure and pulmonary hypertension shortly after birth. When clamping the umbilical cord, a large part of the preload is abruptly excluded, generating an increase in vascular resistance, which in turn increase the afterload, resulting in a decrease in cardiac output. The output is restored by decreasing vascular resistance in pulmonary circuit after lung aeration upon receiving the preload of the right atrium, increasing pulmonary flow and thus sustaining the preload of the left ventricle. If pulmonary aeration occurs before clamping the umbilical cord, the pulmonary blood flow increases before placenta flow is lost, thus avoiding a decrease in cardiac output. This modality has been called physiological base cord clamping (PFC). The hypothesis is that PFC once ventilation has been established could prevent hypoxia and improve cardiac output in newborns with CDH and secondarily improve their hemodynamic parameters, stabilizing gas exchange and pulmonary hypertension during the first 24 hours of birth.",[274,275,276],"Umbilical Cord Clamping","Congenital Diaphragmatic Hernia","Delayed Umbilical Cord Separation","2024-05-06",{"date":279,"type":280},"2024-05-10","ACTUAL",{"date":282,"type":280},"2022-06-14",{"date":284,"type":268},"2026-12-31",{"name":5,"class":6},1]