[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-premature-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-premature-diseases":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,56,79,104,130,158,185,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100563231","phase-1-pkpd-of-digoxin-in-infants-with-svhd-100563231",false,"NCT06613477","PK\u002FPD of Digoxin in Infants With SVHD","Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease","Digoxin R01","Inclusion Criteria:\n\n1. Diagnosis of single ventricle congenital heart disease\n2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation\n3. Age ≤ 30 days of life at time of stage 1 palliation\n4. Age \\\u003C 6 months at time of enrollment\n5. Require treatment with enteral digoxin per their treating medical provider\n6. Informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n1. Gestational age at birth \\\u003C35 weeks\n2. Serum creatinine \\> 2 mg\u002FdL at enrollment\n3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment\n4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment\n5. Known hypersensitivity to digoxin or other forms of digitalis\n6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment\n7. Received digoxin prior to enrollment\n8. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","30 Days","6 Months",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The primary participant will be an infant with single ventricle heart disease.\n\nThis is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function.\n\nThe investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care (\"opportunistic\"). The investigators will also collect information from medical records.\n\nBeing part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.",[29,30,31,32],"Single-ventricle","Infant Conditions","Infant, Newborn, Diseases","Infant, Premature, Diseases",[34,35,36,37,38,39,40,41,42],"Infants","SVD","SVHD","Single Ventricle","Digoxin","Pharmacokinetics","Pharmacodynamics","PK","PD","RECRUITING","2026-01-28",{"date":46,"type":47},"2026-01-30","ACTUAL",{"date":49,"type":47},"2024-10-10",{"date":51,"type":22},"2026-11-30",{"name":53,"class":54},"Duke University","OTHER",2,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100383238","forced-oscillometry-in-infants-with-bronchopulmonary-dysplasia-100383238","NCT04270045","Forced Oscillometry in Infants With Bronchopulmonary Dysplasia","Inclusion Criteria:\n\nPreterm Cohort:\n\n* Premature infants with BPD who are in room air based on the (per NICHD definition)\n* Premature infants with BPD who are receiving low flow O2 support and able to maintain normal spO2 in Room air for brief period ( up to 3 minutes) Term Cohort without pulmonary disease\n* Infants \\>36 weeks gestational age without pulmonary disease\n* Infants \\\u003C 4 weeks of age\n\nOutpatient Cohort:\n\n* Former preterm infants \\\u003C 32 weeks at birth\n* Those with BPD based on NIH 2001 definition\n* Seen prior to 2 years of age\n\nExclusion Criteria:\n\n* Infants with BPD requiring invasive or non-invasive positive pressure ventilation\n* Infants with BPD who have associated genetic diagnosis or major congenital anomalies.",{"count":63,"type":22},80,"OBSERVATIONAL","The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)",[32,67,68],"Bronchopulmonary Dysplasia","Respiratory Distress Syndrome","2026-01-19",{"date":71,"type":47},"2026-01-21",{"date":73,"type":47},"2020-02-06",{"date":75,"type":22},"2027-12-31",{"name":77,"class":54},"Winston Manimtim",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":55},"100609598","multisensory-early-oral-administration-of-human-milk-m-milk-for-very-preterm-infants-100609598","NCT07216664","Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants","Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills","M-MILK RCT","Inclusion Criteria:\n\n* Born at ≤ 32 weeks gestational age.\n* Receiving mother's own milk and\u002For donor human milk at the time of screening.\n\nExclusion Criteria:\n\n* Receiving only formula.\n* Gastrointestinal defects, i.e., cleft lip or cleft palate.\n* Congenital cardiac defects requiring surgery.\n* Necrotizing enterocolitis.\n* Chromosomal abnormalities.","23 Weeks","32 Weeks",{"count":90,"type":22},125,[92],"NA","The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants?\n\nResearchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in:\n\n* Cortisol levels\n* DNA methylation of the two stress related genes (NR3C1 and HSD11B2)\n* Neurodevelopment\n* Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.",[32],"2026-01-16",{"date":97,"type":47},"2026-01-20",{"date":99,"type":47},"2025-11-03",{"date":101,"type":22},"2031-05-31",{"name":103,"class":54},"Loyola University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":78},"100541873","infant-maternal-partnership-and-cognitive-training-study-for-preterm-infants-100541873","NCT06335524","Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants","Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial","IMPACT","Inclusion Criteria:\n\n* inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.\n\nExclusion Criteria:\n\n* a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.","1 Week","17 Weeks",{"count":115,"type":22},188,[92],"This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.",[119,120,32],"Child Development","Infant Development","2025-12-19",{"date":123,"type":47},"2025-12-29",{"date":125,"type":47},"2024-11-01",{"date":127,"type":22},"2028-12",{"name":129,"class":54},"University of Alabama at Birmingham",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100583624","phase-1-dose-finding-for-dobutamine-during-transitional-circulation-in-very-preterm-infants-100583624","NCT06878742","Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants","Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant","NeoCirc-002","Inclusion Criteria:\n\n* Born with up to 32(+6) weeks gestation\n* Presence of hemodynamic insufficiency, defined as SVC flow \\\u003C51 ml\u002Fkg\u002Fmin.\n* Provision of signed and dated informed consent form by father\u002Fmother or legally designated representative, which can be given antenatally.\n\nExclusion Criteria:\n\n* Neonates considered non-viable, with a clinical decision not to provide life support\n* Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment\n* Infants already on dobutamine treatment\n* Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)\n* Infants with chromosomal anomalies\n* Lack of parental signed informed consent","72 Hours",{"count":140,"type":22},30,[25,26],"Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).",[32,144],"Circulatory and Respiratory Physiological Phenomena",[146,147],"Hemodynamic insuffiency","Low superior vena cava flow","2025-03-10",{"date":150,"type":47},"2025-03-17",{"date":152,"type":47},"2024-06-24",{"date":154,"type":22},"2029-06",{"name":156,"class":54},"Instituto de Investigación Hospital Universitario La Paz",3,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":88,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100511706","the-neu-stim-trial-100511706","NCT05942924","The NEU-STIM Trial","A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial","NEU-STIM","Inclusion Criteria:\n\n* Infants born before 32 weeks of gestation can be included in this trial after parental consent.\n\nExclusion Criteria:\n\n* Infants will be excluded if they are found to have a congenital abnormality or condition that has an adverse effect on breathing\u002Fventilation or oxygenation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.",{"count":167,"type":22},3280,[92],"The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.",[32,171],"Birth, Preterm",[173,174,175],"Preterm infant","Tactile stimulation","Resuscitation","2025-03-05",{"date":148,"type":47},{"date":179,"type":47},"2024-03-11",{"date":181,"type":22},"2025-12-31",{"name":183,"class":54},"Leiden University Medical Center",43,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":78},"100441589","optimising-ventilation-in-preterms-with-closed-loop-oxygen-control-100441589","NCT05030337","Optimising Ventilation in Preterms With Closed-loop Oxygen Control","Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants","Inclusion Criteria:\n\n* Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth\n\nExclusion Criteria:\n\n* Preterm infants above 31 weeks completed gestation or term born infants\n* Infants with major congenital abnormalities",{"count":193,"type":22},70,[92],"Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.\n\nOxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.\n\nWith this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.",[32,197,198],"Airway Morbidity","Mechanical Ventilation Complication","2024-10-21",{"date":201,"type":47},"2024-10-23",{"date":203,"type":47},"2021-09-05",{"date":205,"type":22},"2025-03",{"name":207,"class":54},"King's College Hospital NHS Trust",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":214,"sex":215,"minAge":4,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100527269","maternal--infant-morbidity-and-mortality-100527269","NCT06145568","Maternal & Infant Morbidity and Mortality","Inclusion Criteria:\n\n* pregnant women\n\nExclusion Criteria:\n\n* N\u002FA",true,"FEMALE",{"count":217,"type":22},1000,"The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children.\n\nThe EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty\u002Fstaff.",[220,32,221,222,223],"Preg Complications: Hemorrhagic","Preg Complications: Hemorrhagic Intervillous of Placenta","Preg Complications: Bleeding From Female Genital Tract","Preg Complic - Malig Hypertension and \u002F or Reason for Care During Childbirth",[225],"pregnancy complications; hemorrhagic; hypertension; premature infants; bleeding","NOT_YET_RECRUITING","2023-11-17",{"date":229,"type":47},"2023-11-24",{"date":231,"type":22},"2023-12-01",{"date":233,"type":22},"2033-12-31",{"name":235,"class":54},"University of Virginia"]