[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lung-disease-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lung-disease-of-prematurity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100305213","phase-2-a-clinical-efficacy-and-safety-study-of-ohb-607-in-preventing-bronchopulmonary-dysplasia-in-extremely-premature-infants-100305213",false,"NCT03253263","A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants","A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity","Inclusion Criteria:\n\n1. Written informed consents and\u002For assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB\u002FIEC (in accordance with local regulations).\n2. Written informed consents and\u002For assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB\u002FIEC (in accordance with local regulations).\n3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.\n\nExclusion Criteria:\n\n1. Detectable major (or severe) congenital malformation identified before randomization.\n2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.\n3. Hypoglycemia at Baseline (blood glucose less than (\\\u003C) 45 milligrams per deciliter \\[mg\u002FdL\\] or 2.5 milli moles per liter \\[mmol\u002FL\\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.\n4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.\n5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.\n6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).\n7. The participant or participant's parent(s) is\u002Fare unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.\n8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.\n9. Birth mother with known HIV or hepatitis (B, C, or E) infection.","ALL","0 Hours","24 Hours",{"count":20,"type":21},338,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.",[27,28,29,30],"Bronchopulmonary Dysplasia","Chronic Lung Disease of Prematurity","Intraventricular Hemorrhage","Retinopathy of Prematurity (ROP)","RECRUITING","2026-06-10",{"date":34,"type":35},"2026-06-11","ACTUAL",{"date":37,"type":35},"2019-05-09",{"date":39,"type":21},"2028-01-21",{"name":41,"class":42},"OHB Neonatology Ltd.","INDUSTRY",72,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100524572","reversibility-of-bronchial-obstruction-in-children-born-preterm-100524572","NCT06110481","Reversibility of Bronchial Obstruction in Children Born Preterm","Bronchodilator Response To Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm","Inclusion Criteria:\n\n* children born preterm \u002Fbefore the 35th week of gestational age (35+0)\u002F\n* all subjects must have chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry\n* subjects must be able to cooperate well in spirometry\n\nExclusion Criteria:\n\n* The presence of another chronic respiratory disease (e.g., cystic fibrosis, primary ciliary dyskinesia, etc.). Asthma bronchiale is not an exclusion criterion, but subjects with CLDI combined with asthma bronchiale represent a specific subgroup of subjects and we perform a standardized therapeutic test with inhaled corticosteroids (ICS) administered for at least 12 weeks via a pressurized aerosol dispenser (pMDI) via an inhaler attachment before enrollement.\n* Insufficient cooperation during spirometry.","5 Years","18 Years",{"count":54,"type":21},80,"OBSERVATIONAL","This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI).\n\nThe main questions are:\n\n* Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction?\n* Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI?\n\nParticipants will:\n\n* Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator.\n* They will then perform a spirometry test before and after the inhalation of the drug.\n* This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).",[27,28,58,59,60,61,62],"Chronic Lung Disease of Newborn","Preterm Birth Complication","Bronchial Hyperreactivity","Bronchial Obstruction","Reversible Dilatation","2025-05-19",{"date":65,"type":35},"2025-05-22",{"date":67,"type":35},"2021-04-01",{"date":69,"type":21},"2026-01-01",{"name":71,"class":72},"Charles University, Czech Republic","OTHER",1]