[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572051":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":18,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":81,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fetal Care Center, PLLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amnioinfusion","EXPERIMENTAL","Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.",[13],"Other: Amnioinfusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Comfort Care\u002FExpectant Management","NO_INTERVENTION","The non-experimental arm, Comfort Care\u002FExpectant Management, will undergo comfort care as elected by the participant.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","A 20- or 22-gauge spinal needle (routinely used obstetrics and gynecology needle) will be used by an expert in fetal procedures with sterile technique to access the amniotic cavity under real-time ultrasound guidance to infuse isotonic fluid (Lactated Ringers with 1g\u002FL of Oxacillin). This fluid will act as replacement amniotic fluid. Regular monitoring of fluid levels may suggest serial infusion, which will be completed as deemed necessary by the study doctor.",[9],[25],"Amniotic fluid injection",[27],{"name":28,"role":29,"phone":30,"phoneExt":18,"email":31},"Kevin P Magee, M.D.","CONTACT","(972) 566-5600","kevin.magee@fetalcaredallas.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fetal Care Center","RECRUITING","Dallas","Texas","75230","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-96.80667,32.78306,{"lat":45,"lon":44},[48],{"name":28,"role":29,"phone":30,"phoneExt":18,"email":31},{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52,54],{"name":53,"class":21},"Medical City Children's Hospital",{"name":55,"class":56},"Medical City Women's Hospital","UNKNOWN","100572051","amnioinfusion-for-fetal-renal-failure-100572051",false,"NCT06728228","Amnioinfusion for Fetal Renal Failure","Inclusion criteria:\n\n1. Confirmed anhydramnios before 22 weeks GA for patients with FRF.\n2. Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6\u002F7 days GA.\n3. Confirmation that the expectant mother understands her options for management of the pregnancy.\n4. Age ≥18 years of age.\n5. Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.\n6. Willingness for postnatal care to be performed at Medical City Dallas Hospital\u002Fthe Fetal Care Center until maternal discharge.\n7. Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.\n\nExclusion criteria:\n\n1. Cervix less than 2.5 cm in length.\n2. No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).\n3. Other significant congenital anomalies in the fetus.\n4. Evidence of chorioamnionitis or abruptio placentae.\n5. Evidence of rupture of membranes or chorionic-amniotic separation.\n6. Evidence of preterm labor.\n7. Multiple gestation.\n8. Severe maternal medical condition in pregnancy.\n9. Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.\n10. Technical limitations precluding amnioinfusion.","FEMALE",{"count":65,"type":66},35,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are:\n\n* Can serial amnioinfusion increase the chances of survival for these fetuses?\n* Does this procedure improve chances of survival until dialysis and\u002For kidney transplant?\n\nParticipants will:\n\n* Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity.\n* Undergo monitoring to check the effects on the fetus and mother.\n\nThis study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.",[72,73,74,75,76,77,78,79,80],"Multicystic Dysplastic Kidney","Polycystic Kidney Disease","Fetal Renal Anomaly","Anhydramnios","Potter Syndrome","Lung Hypoplasia","Multicystic Renal Dysplasia, Bilateral","Lower Urinary Tract Obstructive Syndrome","Bilateral Renal Agenesis",[82,83,84,85],"Fetal Renal Failure","Kidney Disease","MCDK","PCKD","2024-12-18",{"date":88,"type":89},"2024-12-20","ACTUAL",{"date":91,"type":89},"2024-12-05",{"date":93,"type":66},"2026-11-15",{"name":5,"class":6},1]