[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bpd---bronchopulmonary-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bpd---bronchopulmonary-dysplasia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,83,116,140,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100488152","safety-and-pk-pd-study-of-oral-l-cit-in-preterm-infants-with-bpdph-and-nec-100488152",false,"NCT05636397","Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC","A Phase I, Safety and Pharmacokinetics\u002FPharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC","Arm 1: BPD±PH:\n\nInclusion Criteria:\n\n* Born ≤ 30 weeks at birth\n* Post-menstrual age (PMA) ≥ 32 weeks\n* Echocardiographic evidence of PH for infants with BPD+PH.\n* On invasive or non-invasive ventilation with RSS \\>2.0 for \\>12hours\u002Fday for at least 48 hours as an early predictor of evolving BPD\n* Informed written consent (parents\u002Fsubstitute decision maker)\n\nExclusion Criteria\n\n* Congenital Heart Disease \\[Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)\\]\n* Infants with pulmonary vein stenosis\n* Concurrent sepsis with hemodynamic instability\n* Infants considered likely to die within next 7 days\n* Any other condition that, in the opinion of the investigator, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant\n\nArm 2: surgical NEC\n\nInclusion Criteria:\n\n* Born ≤ 30 weeks at birth\n* Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)\n* Tolerating 50 ml\u002Fkg\u002Fday of enteral feeds\n* Informed written consent (parents\u002Fsubstitute decision maker)\n* Considered medically stable by clinical team\n\nExclusion Criteria\n\n* Congenital heart disease (except small ASD, small VSD and non hsPDA)\n* Pulmonary vein stenosis\n* Concurrent sepsis with hemodynamic instability\n* Likely to die within next 7 days\n* Other condition significantly affecting pulmonary function independent of prematurity or NEC","ALL","1 Month","6 Months",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the safety and explore the PK\u002FPD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post-surgical NEC and BPD±PH.",[27,28,29],"BPD - Bronchopulmonary Dysplasia","Pulmonary Hypertension","NEC",[31,32,33,34,35,36],"BPD±PH","surgical NEC","L-Citrulline","Pharmacokinetic profile","Pharmacodynamic profile","Preterm neonates","RECRUITING","2026-04-28",{"date":40,"type":41},"2026-05-04","ACTUAL",{"date":43,"type":41},"2023-11-01",{"date":45,"type":21},"2028-03",{"name":47,"class":48},"The Hospital for Sick Children","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100625120","phase-2-pressure-targeting-during-high-flow-therapy-in-premature-infants-100625120","NCT07418502","Pressure Targeting During High Flow Therapy in Premature Infants","A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants","NeoMATCH","Inclusion Criteria:\n\n* Delivery at \\>24+0 weeks and ≤32+6 weeks of gestation\n* Postnatal age \\>7 days but \\\u003C 6 weeks old\n* Weight ≥1,000grams at the time of study\n* Receiving clinically prescribed CPAP at pressures of 5-8cm H2O\n* Requiring an FiO2 of ≤0.60\n\nExclusion Criteria:\n\n* Chromosomal disorder (aneuploidy)\n* Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)\n* Prior pneumothorax\n* Infants in whom chance of survival is uncertain","7 Days","40 Weeks",{"count":61,"type":21},78,[63],"PHASE2","The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is:\n\nDoes Pressure Targeted High Flow provide enough support in premature infants?\n\nParticipants will:\n\nTake spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.",[66,67,27],"Preterm Infants","Respiratory Distress Syndrome (Neonatal)",[69,70,71],"preterm","CPAP","High Flow","NOT_YET_RECRUITING","2026-02-10",{"date":75,"type":41},"2026-02-18",{"date":77,"type":21},"2026-05-01",{"date":79,"type":21},"2027-09",{"name":81,"class":48},"University of Texas at Austin",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100605391","controlled-remote-monitoring-and-optimization-of-oxygen-therapy-in-preterm-infants-100605391","NCT07161908","Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants","Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy","Inclusion Criteria:\n\n* infants born before 31+6 weeks gestation\n* signed consent for participation in the project and consent for the processing of personal data\n* diagnosed with bronchopulmonary dysplasia\n* type of pulmonary ventilation - low-flow nasal cannulas\n\nExclusion Criteria:\n\n* unsigned consent for participation in the project and\u002For consent for the processing of personal data\n* child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea\n* other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration\n* insufficient therapy through long-term home oxygen therapy\n* tracheostomy","36 Weeks",{"count":92,"type":21},70,[24],"The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.",[27,28],[97,98,99,100,101,102,103,104],"BPD","Bronchopulmonary Dysplasia","preterm infants","oxygen therapy","telemedicine","remote monitoring","pulmonary hypertension","Czech Republic","2025-09-04",{"date":107,"type":41},"2025-09-09",{"date":109,"type":41},"2025-08-25",{"date":111,"type":21},"2027-02",{"name":113,"class":114},"Institute of Health Information and Statistics of the Czech Republic","OTHER_GOV",4,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":115},"100521101","early-life-mri-biomarkers-of-longer-term-respiratory-morbidity-in-infants-born-extremely-preterm-emblem-100521101","NCT06065215","Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)","EMBLEM","Inclusion Criteria:\n\n1. Infants born at \\\u003C29 weeks gestation;\n2. currently \\\u003C36 weeks PMA.\n\nExclusion Criteria:\n\n1. Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect\u002Fhemodynamically insignificant ventricular septal defect\u002Fpatent ductus arteriosus);\n2. genetic syndrome or congenital anomaly;\n3. contraindications for MRI or transport;\n4. invasive or non-invasive ventilation that cannot be safely removed for MRI;\n5. current respiratory infection;\n6. family cannot speak English\u002FFrench;\n7. transferred to another hospital prior to baseline study visit\n8. not receiving follow-up at one of the study centres.","35 Weeks","21 Months",{"count":126,"type":21},319,"OBSERVATIONAL","Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.",[130,27],"Lung Function","2025-02-21",{"date":133,"type":41},"2025-02-24",{"date":135,"type":41},"2024-03-30",{"date":137,"type":21},"2027-06-30",{"name":139,"class":48},"Children's Hospital of Eastern Ontario",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":49},"100576682","phase-1-safety-and-efficacy-of-umbilical-cord-derived-mesenchymal-stem-cellmsc-transplantation-in-the-treatment-of-bronchopulmonary-dysplasiabpd-in-premature-infants-100576682","NCT06788470","Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants","Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants","MSC，BPD","Inclusion Criteria:\n\n1. 23-29 weeks of gestation, birth weight 500-1500g;\n2. For patients with no improvement or aggravation of lung condition after DART hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks.\n3. Children with severe BPD after early use of PS\n4. Parents agree to participate in clinical trials.\n\nExclusion Criteria:\n\n1. Premature infants not suitable for the given gestational age;\n2. Other congenital structural malformations of trachea, bronchus and lungs;\n3. Complicated with severe congenital heart disease;\n4. Complicated with Periventricular Leukomalacia (PVL);\n5. Complicated with intraventricular hemorrhage (IVH) above level 3;\n6. Septic shock or positive blood culture;\n7. Acute pulmonary hemorrhage;\n8. Intracranial and extracranial diseases affecting respiratory rate and rhythm.",{"count":149,"type":21},10,[151,63],"PHASE1","Bronchopulmonary dysplasia (BPD) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants. Moderate and severe BPD survivors are prone to adverse outcomes such as impaired lung function, childhood exercise intolerance, and neurodevelopmental retardation in the long term, which seriously affects their quality of life and brings a heavy burden to society and families. However, the pathogenesis of BPD is complex, including pulmonary vascular dysplasia, lung inflammation, and impaired alveolar development. There is currently no specific clinical drug to cure BPD. Mesenchymal stem cells (MSCs) are a kind of multipotent stem cells that exist in almost all organs and tissues of individuals. MSCs have the properties including self-renewal, multi-directional differentiation, and immunosuppressive and anti-inflammatory abilities. Preclinical studies have shown that MSCs can alleviate BPD by improving alveolar and pulmonary vascular development, and reducing pulmonary fibrosis. Several phase I clinical studies have demonstrated that intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells for children with BPD is safe and feasible.\n\nThis study aims to further evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation in the treatment of severe BPD in premature infants, in the hope of increasing the survival rate and improving the prognosis of severe BPD.",[27],[155,156,157],"Bronchopulmonary dysplasia (BPD)","Mesenchymal stem cells (MSCs)","Premature infants","2025-01-22",{"date":160,"type":41},"2025-01-23",{"date":162,"type":41},"2024-08-09",{"date":164,"type":21},"2027-08-09",{"name":166,"class":48},"The Children's Hospital of Zhejiang University School of Medicine",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":177,"conditions":178,"keywords":184,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100519559","pufas-in-preterm-infants-100519559","NCT06045130","PUFAs in Preterm Infants","Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis","PIPI","Inclusion Criteria:\n\nInfants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.\n\n\\-\n\nExclusion Criteria:\n\nInfants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.\n\n\\-",{"count":176,"type":21},600,"The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.",[179,180,27,181,182,183],"Necrotizing Enterocolitis","Intraventricular Hemorrhage","Sepsis","Periventricular Leukomalacia","Patent Ductus Arteriosus",[185],"PUFAs","2023-09-13",{"date":188,"type":41},"2023-09-21",{"date":188,"type":21},{"date":191,"type":21},"2026-08-31",{"name":193,"class":48},"The First Hospital of Jilin University"]