[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchopulmonary-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchopulmonary-dysplasia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,47,73,102,127,152,180,207,232,260,293,321,339,360,389,416,429,448,473,521,542,572,596,634,653],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053959","phase-2-lipid-infusions-to-optimize-nutrition-trial-100053959",false,"NCT06915441","Lipid Infusions to Optimize Nutrition Trial","Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial","LION","Inclusion Criteria:\n\n* inborn \\\u003C28 weeks gestational age (GA) or ≤1000g birth weight (BW)\n* survives until 12 hours after birth.\n\nExclusion Criteria:\n\n* Infants who are unable to be enrolled by 96 hours postnatal age\n* Major anomaly\n* Overt non-bacterial infection\n* Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.","ALL","12 Hours","28 Weeks",{"count":22,"type":23},230,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based lipid emulsion (SOLE) and to establish whether MOLE or SOLE is more effective in minimizing pulmonary outcomes, neonatal morbidities, long-term morbidity and mortality, and improving discharge growth and Bayley Scales of Infant Development Fourth Edition (BSID-IV) neurodevelopmental assessment at two years",[29,30],"Bronchopulmonary Dysplasia","Neurodevelopmental Impairment",[32,33],"soybean oil-based lipid emulsion (SOLE)","mixed oil lipid emulsion (MOLE)","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":23},"2030-12-31",{"name":44,"class":45},"The University of Texas Health Science Center, Houston","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100557149","transpyloric-versus-gastric-feeding-in-bronchopulmonary-dysplasia-100557149","NCT06534359","Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia","Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n1. Birth \\\u003C32 weeks' gestation\n2. Current postmenstrual age of 36-65 weeks\n3. Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L\u002Fmin flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings\n4. Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment\n\n(4) Full gastric tube feedings (≥100mL\u002Fkg\u002Fd) at the time of enrollment (5) Parental consent to participate\n\nNote: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.\n\nExclusion Criteria:\n\n1. Transpyloric feedings received within 7d of enrollment\n2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment\n3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding\n4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial\n5. Known intolerance to transpyloric feeding\n6. Persistent \\>20% endotracheal tube leak (for intubated subjects only)\n7. Active treatment with an investigational therapy as part of another interventional trial\n8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function","1 Month","12 Months",{"count":57,"type":23},60,[59],"NA","The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are:\n\nDoes transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events?\n\nDoes transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring?\n\nParticipants will:\n\nUndergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER.\n\nBe randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks.\n\nUndergo repeat pH-MII at the end of the 2 week trial to assess for change in GER.\n\nUndergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial.\n\nUndergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER.\n\nBe monitored clinically for possible adverse events.",[29,62],"Gastroesophageal Reflux","2026-06-26",{"date":65,"type":38},"2026-06-30",{"date":67,"type":38},"2025-07-15",{"date":69,"type":23},"2027-06-30",{"name":71,"class":45},"Children's Hospital of Philadelphia",4,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100498996","randomized-controlled-crossover-trial-of-postpyloric-feedings-to-improve-pulmonary-outcomes-in-high-risk-preterm-infants-100498996","NCT05777512","Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","Inclusion Criteria:\n\nPreterm infants born \\\u003C 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:\n\n1. Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP \\> 5cm H2O or CPAP 5 with FiO2 \\> 21%.\n2. Have ongoing need for respiratory support due to underlying lung disease from prematurity.\n3. Are tolerating \\> 80 ml\u002Fkg\u002Fday of enteral feedings at baseline, either via nasogastric (NG) or nasojejunal (NJ) tube. Patients may be receiving gastric (NG) or postpyloric (NJ) feedings.\n\nExclusion Criteria:\n\n1. Infants who are transiently on respiratory support at the time of study entry due to another reason than underlying lung disease from prematurity; for example, recovery from a surgical intervention.\n2. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities.\n3. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment.\n4. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.","0 Hours","1 Year",{"count":83,"type":23},50,[59],"The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.",[29],[88,89,90,29,91,92],"Chronic Lung Disease of Prematurity","Postpyloric Feeding","Nasojejunal Feeding","GERD","Gastro-esophageal Reflux","2026-06-25",{"date":95,"type":38},"2026-06-29",{"date":97,"type":38},"2024-04-26",{"date":99,"type":23},"2028-02",{"name":101,"class":45},"Boston Children's Hospital",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100473544","the-diaphragmatic-initiated-ventilatory-assist-diva-trial-100473544","NCT05446272","The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial","DIVA","Inclusion Criteria:\n\n* Gestational age of 23 0\u002F7- 28 6\u002F7 weeks at birth\n* Intubated in the first 7 days of life\n* Undergoing extubation following at least 12 hours of invasive mechanical ventilation\n* Post-natal age \\\u003C32 weeks Post menstrual age at time of extubation\n\nExclusion Criteria:\n\n* Major congenital anomalies, including pulmonary hypoplasia\n* Neurologic disorders affecting respiratory drive (other than apnea of prematurity)\n* Esophageal bleeding or other contraindication to NG\u002FOG catheter placement\n* Current weight \\\u003C500 grams (based on Edi catheter approval)\n* Study ventilator not available at time eligibility criteria are met\n* Planned surgery or invasive procedure within 5 days of extubation\n* Informed consent not provided","0 Days","9 Weeks",{"count":112,"type":23},478,[59],"DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0\u002F7-28 6\u002F7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.",[116,29,117],"Extubation Failure","Death","2026-06-24",{"date":93,"type":38},{"date":121,"type":38},"2022-08-03",{"date":123,"type":23},"2027-12-31",{"name":125,"class":45},"University of Pennsylvania",20,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":18,"minAge":54,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100544776","pulmonary-hypertension-and-oxygen-saturation-targeting-in-preterm-infants-100544776","NCT06373289","Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants","Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension","PHOX","Inclusion Criteria:\n\n* Between 22w 0\u002F7d and 31w 6\u002F7d gestation at birth\n* Diagnosed with echocardiographic pulmonary hypertension (1) \\>20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index \\>1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg\n* Receiving supplemental oxygen\n* Have mature retinas\n\nExclusion Criteria:\n\n* Major congenital anomalies",true,"5 Months",{"count":5,"type":23},[59],"Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.",[29,141],"Pulmonary Hypertension","2026-06-16",{"date":144,"type":38},"2026-06-17",{"date":146,"type":23},"2026-07-15",{"date":148,"type":23},"2029-12-01",{"name":150,"class":45},"University of Alabama at Birmingham",2,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":46},"100642221","octa-evaluation-of-retinal-vascularization-in-preterm-infants-with-or-without-bronchopulmonary-dysplasia-100642221","NCT07586683","OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia","OCTA_BRO","Inclusion Criteria:\n\n* Preterm group:\n\nAny child aged 5 to 15 years born at or before 28 weeks' gestation (with or without bronchopulmonary dysplasia), followed or not at CHIC.\n\n-Control group: Any child aged 5 to 15 years born at or after 38 weeks' gestation, attending ophthalmology consultations at CHIC.\n\n* Agreement to participate in the study protocol\n* Child living near CHI Créteil\n* Enrolled in a social security scheme\n\nExclusion Criteria:\n\n* Neurobehavioral disorders or psychomotor delay preventing the examination from being performed\n* Presence of ROP (retinopathy of prematurity) involving zone I or having received intravitreal injections (IVT) of anti-VEGF (as this may directly alter OCT-A parameters)\n* Pre-existing retinal disease: macular scar of any cause, retinal vascular abnormalities such as sickle cell disease or diabetes\n* Pre-existing optic nerve diseases: glaucoma, coloboma, tumors\n* Chronic respiratory diseases other than BPD (bronchopulmonary dysplasia) (i.e., not associated with prematurity): cystic fibrosis, bronchiectasis, etc.\n* General condition unrelated to prematurity that may have a retinal impact: for example respiratory diseases other than BPD\n* Participation in an interventional ophthalmology study\n* History of febrile seizures in infancy or epilepsy contraindicating the use of eye drops","5 Years","15 Years",{"count":162,"type":23},56,[59],"Retinal vascularization in humans develops between the 16th and 36th weeks of amenorrhea, in a centrifugal pattern starting from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development.\n\nPrematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction, thereby worsening the existing ischemia. This raises the question of whether subclinical retinal vascular changes, detectable by OCT angiography, may explain the increased risk of amblyopia and the need for optical correction observed in these patients.\n\nOCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, fast, reliable, and non-invasive examination, requiring no injection, that enables high-resolution visualization of retinal vascularization, with separate analysis of the retinal plexuses and the choriocapillaris.",[29],[167,168,169],"OCT_A","children born prematurely","Bronchopulmonary dysplasia","NOT_YET_RECRUITING","2026-06-11",{"date":173,"type":38},"2026-06-15",{"date":175,"type":23},"2026-06",{"date":177,"type":23},"2028-05",{"name":179,"class":45},"Centre Hospitalier Intercommunal Creteil",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":24,"phases":192,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":46},"100616592","phase-1-high-energy-human-milk-diets-in-the-first-two-weeks-after-birth-to-reduce-bpd-in-extremely-preterm-infants-100616592","NCT07307612","High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants","Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial","MEND-BPD","Inclusion Criteria:\n\n* Gestational age ≤ 28 weeks of gestation\n* Postnatal age \\\u003C 72 hours\n\nExclusion Criteria:\n\n* Congenital malformations\n* Chromosomal anomalies\n* Terminal illness needing to limit or withhold support","1 Day","3 Days",{"count":191,"type":23},150,[193,26],"PHASE1","This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA\u002FARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).",[196,197,29],"Extreme Prematurity","Enteral Nutrition",[199],"Prematurity; Extreme",{"date":201,"type":38},"2026-06-12",{"date":203,"type":23},"2026-08-15",{"date":205,"type":23},"2029-07-31",{"name":150,"class":45},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":24,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":231},"100305213","phase-2-a-clinical-efficacy-and-safety-study-of-ohb-607-in-preventing-bronchopulmonary-dysplasia-in-extremely-premature-infants-100305213","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.","24 Hours",{"count":216,"type":23},338,[26],"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.",[29,88,220,221],"Intraventricular Hemorrhage","Retinopathy of Prematurity (ROP)","2026-06-10",{"date":171,"type":38},{"date":225,"type":38},"2019-05-09",{"date":227,"type":23},"2028-01-21",{"name":229,"class":230},"OHB Neonatology Ltd.","INDUSTRY",72,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":72},"100643359","lung-ultrasound-score-for-early-prediction-of-bronchopulmonary-dysplasia-in-preterm-newborns-100643359","NCT07633184","Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns","Lung Ultrasound Score (LUS) as Early Predictor of Bronchopulmonary Dysplasia (BPD) in Preterm Newborns: A Prospective, Multicenter, Observational Study","LUS_BPD","Inclusion Criteria:\n\n* born at less than 32 weeks' gestational age;\n* born in the Neonatology Department of one of the centres participating in the study or transferred there from another hospital within the first week of life;\n* parents\u002Fguardians have signed an informed consent form regarding the inclusion of thenewborn in the study and consent to the processing of personal data\n\nExclusion Criteria:\n\n* major malformations,chromosomal abnormalities, congenital chest wall deformities, congenital heart defects, pulmonary hypoplasia, diaphragmatic hernia, suspected muscular dystrophy or neurological disorders that may impair lung development;\n* receipt of palliative care from birth;\n* death before 36 weeks' gestational age;\n* inability to perform a chest ultrasound or to adequately examine all 6 lung fields at both 7 (+\u002F-1) and 14 (+\u002F-2) days for any intervening reason;\n* inability to collect the data necessary to formulate a diagnosis of BPD within the duration of the study","31 Weeks",{"count":242,"type":23},40,"OBSERVATIONAL","Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation. Despite advances in neonatal care and improved survival rates for extremely preterm infants, the incidence of BPD remains high. BPD is associated with significant short- and long-term morbidity, including chronic respiratory impairment, pulmonary hypertension, recurrent respiratory infections, and neurodevelopmental sequelae. Current diagnosis of BPD is based on the need for respiratory support at 36 weeks postmenstrual age, limiting opportunities for early therapeutic intervention. Since structural lung injury may become irreversible within the first weeks of life, the identification of reliable early predictors of BPD is a major clinical priority. Lung ultrasound (LUS) is a non-invasive, radiation-free, bedside imaging technique increasingly used in neonatal intensive care units. The Lung Ultrasound Score (LUS) provides a quantitative assessment of lung aeration and has demonstrated utility in predicting several neonatal respiratory outcomes. Recent studies suggest that both LUS and pleural line abnormalities detected during the first weeks of life may be associated with the subsequent development of BPD, although evidence remains heterogeneous and no universally validated predictive method is currently available.",[29],[247,248,249],"respiratory morbidity","prematurity","dysplasia","2026-06-03",{"date":252,"type":38},"2026-06-08",{"date":254,"type":38},"2024-11-02",{"date":256,"type":23},"2027-02",{"name":258,"class":259},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":268,"minAge":269,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":46},"100636779","phase-1-pharmacokinetics-and-placental-transfer-of-caffeine-100636779","NCT07570121","Pharmacokinetics and Placental Transfer of Caffeine","Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy","AnteCaff","Inclusion Criteria:\n\n1. Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery.\n2. Informed consent provided for participation.\n3. Cesarean delivery.\n\nExclusion Criteria:\n\n1. Known major fetal congenital anomalies or genetic disorders.\n2. Plan in place for limited neonatal resuscitation or comfort care only.\n3. Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.\n4. Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.\n5. Fetal arrhythmia.\n6. Seizure disorder.\n7. Oligohydramnios due to renal anomalies or renal impairment.\n8. Current or anticipated use of products that include sodium benzoate.\n9. Maternal age \\\u003C18 years.\n10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated.\n11. High likelihood of receiving terbutaline.\n12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.\n13. Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.","FEMALE","18 Years",{"count":271,"type":23},30,[193],"The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.",[275,276,277,278,29],"Preterm Labor With Preterm Delivery","Premature Birth","Apnea of Prematurity","Respiratory Distress Syndrome",[280,281,248,282,283,284],"caffeine","preterm labor","pharmacokinetics","bronchopulmonary dysplasia","apnea of prematurity",{"date":286,"type":38},"2026-06-04",{"date":288,"type":38},"2026-06-01",{"date":290,"type":23},"2027-06",{"name":292,"class":45},"Indiana University",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":83},"100585090","phase-2-efficacy-and-safety-of-zelpultide-alfa-in-preterm-neonates-at-high-risk-of-developing-bronchopulmonary-dysplasia-bpd-100585090","NCT06897839","Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)","Randomized, Double-Blind Parallel-Group, Adaptive, Three-Arm, Phase 2b\u002F3 Multicenter Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preventing Bronchopulmonary Dysplasia (BPD) in High-Risk Preterm Neonates Compared to Standard of Care (SOC)","ZELA","Inclusion Criteria:\n\n1. Born between gestational age (GA) 22 0\u002F7 to 27 6\u002F7 weeks, inclusive.\n2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth.\n3. Intubated and on invasive mechanical ventilation per SOC.\n4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met.\n5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n1. Birth weight \\\u003C 400 g or \\> 1,500 g.\n2. Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to:\n\n   * Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies,\n   * Clinically relevant congenital diaphragmatic hernia,\n   * Omphalocele or gastroschisis, esophageal atresia,\n   * Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc).\n3. Active do no resuscitate (DNR) order in place.\n4. History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.\n5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA.\n6. Any condition or situation that, in the Investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.","0 Minutes","96 Hours",{"count":304,"type":23},366,[26,306],"PHASE3","This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b\u002F3 study with an adaptive seamless design.\n\nThe goal fo this study is to determine if an investigational drug, Zelpultide Alfa, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies.\n\nThe study comprises 2 parts:\n\n* Part 1: Phase 2b, dose selection and exploratory efficacy and safety.\n* Part 2: Phase 3, confirmatory efficacy and safety.\n\nIn Part 1, the study subjects will be randomized with a 1:1:1 allocation ratio to either :\n\n1. Standard of care + zelpultide alfa 4 mg\u002Fkg or,\n2. Standard of care + zelpultide alfa 6 mg\u002Fkg or,\n3. Standard of care + placebo (air-sham).\n\nIn Part 1, all three arms will be evaluated descriptively to support dose selection based on safety, tolerability, and exploratory efficacy signals. Upon completion of Part 1, the DSMC will recommend which Phase 2b dose (\"selected dose\") to progress into Part 2 to the Study Steering Committee, which will decide the dose for Part 2 (Phase 3). A sample size reassessment will be performed after Part 1 completion.\n\nIn Part 2, the selected dose of zelpultide alfa will be compared against placebo (air-sham) in a confirmatory analysis on the primary and key secondary endpoints. The study subjects will be randomized with a 1:1 allocation ratio to either:\n\n1. Standard of care + zelpultide alfa (selected dose from Part 1), or\n2. Standard of care + placebo (air-sham). The main objective in part 2 is to compare the efficacy of zelpultide alfa added to standard of care versus standard of care plus placebo (air-sham) in terms of incidence of grade 2 and grade 3 bronchopulmonary dysplasia (BPD) and death in neonates at high risk for developing BPD.\n\nIn both parts, treatment will be administered intratracheally. Participants will receive up to 7 administrations of zelpultide alfa at (4mg\u002Fkg or 6 mg\u002Fkg) or air-sham in 24 h intervals while the subjects are still intubated per standard of care.",[29],[310,311,312],"BPD","Zelpultide alfa","AT-100","2026-06-02",{"date":250,"type":38},{"date":316,"type":38},"2025-02-03",{"date":318,"type":23},"2030-04-30",{"name":320,"class":230},"Airway Therapeutics, Inc.",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":81,"enrollmentInfo":327,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":46},"100461185","implementation-of-a-consensus-based-discharge-protocol-for-preterm-infants-with-lung-disease-100461185","NCT05285345","Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease","Inclusion Criteria:\n\n* Preterm infants born \\\u003C32 weeks with at least mild BPD, defined as 28 days of respiratory support after birth.\n* Efforts will be made to include a mix of infants with mild, moderate, and severe BPD, including infants discharged on oxygen.\n\nExclusion Criteria:\n\n* Discharge to a location other than home.\n* Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.",{"count":83,"type":23},"The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction\u002Ffeedback with implementation of these guidelines.",[29],[29,331],"NICU Discharge","2026-05-31",{"date":313,"type":38},{"date":335,"type":38},"2023-09-27",{"date":337,"type":23},"2027-11",{"name":101,"class":45},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":135,"sex":18,"minAge":4,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":46},"100587205","phase-2-ivig-trial-for-the-treatment-of-bronchopulmonary-dysplasia-100587205","NCT06925360","IVIG Trial for the Treatment of Bronchopulmonary Dysplasia","The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n* Gestational age between 25 weeks and 29 weeks + 6 days\n* Admission within 24 hours after birth.\n* Clinical symptoms and chest X-ray results show a highly suspicion of BPD （Clinical symptoms and chest X-ray changes of BPD）.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.\n* A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.\n\nExclusion Criteria:\n\n* Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)\n* Chromosomal defects (e.g., trisomy 13, 18, 21)\n* Severe intracranial hemorrhage\n* Multiple organ failure\n* With severe lung infections\n* Other circumstances that the investigator determines are not suitable for participation in this study","10 Weeks",{"count":126,"type":23},[26],"It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. Participants will received continuous infusion IVIG 1 g\u002Fkg\u002Fday for the first 2 days, 0.5 g\u002Fkg\u002Fday for next 3 days (total does 3.5 g\u002Fkg), repeatable if necessary.",[29],"2026-05-22",{"date":353,"type":38},"2026-05-27",{"date":355,"type":38},"2025-04-12",{"date":357,"type":23},"2027-12",{"name":359,"class":45},"International Peace Maternity and Child Health Hospital",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":368,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":378,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":46},"100555503","ventilator-pressure-and-optimization-of-compliance-and-hemodynamics-100555503","NCT06512935","Ventilator Pressure and Optimization of Compliance and Hemodynamics","Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial","VPOCH","Inclusion Criteria:\n\nPreterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \\\u003C 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.\n\n* Post-natal age \\> 7 days and less than 1 month (outside golden week protocol)\n* Gestational age ≥ 21 weeks and ≤ 34 week\n* Infants with written informed consent obtained from legal guardian\n\nExclusion Criteria:\n\n* Blood culture-positive sepsis\n* Congenital anomalies affecting respiration\n* Cyanotic or ductal-dependent congenital heart disease\n* Newborns who are considered too unstable for study enrolment per neonatology attending\n* Newborns on pressors or steroids for maintaining cardiac output\n* Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)\n* Open skin wounds or abrasions on the chest wall.","7 Days","30 Days",{"count":371,"type":23},24,[59],"In preterm infants \\\u003C 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants.\n\nInfants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.",[29,375,196,376,377],"Pulmonary Hypertension Due to Lung Diseases and Hypoxia","Ventilator Lung; Newborn","Ventilation Perfusion Mismatch",[379,380,381],"Respiratory distress syndrome","ventilation mechanics in newborn","cardiac hemodynamics newborn","2026-05-06",{"date":384,"type":38},"2026-05-11",{"date":386,"type":23},"2026-08-01",{"date":69,"type":23},{"name":150,"class":45},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":397,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":24,"phases":400,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100589417","restricted-versus-liberal-fluid-intake-for-prevention-of-bronchopulmonary-dysplasia-100589417","NCT06954142","Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia","Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia - RELIEF Trial. A Cluster-randomised Multiple Period Cross-over Trial.","RELIEF","Inclusion Criteria:\n\n* Hospitalised preterm infants born before 30 weeks 0 days gestation\n* Signed informed consent for further research use of health-related data\n\nExclusion Criteria:\n\n* congenital malformations\n* diseases likely to affect life expectancy, lung function, fluid strategy, or neurodevelopment\n* renal disease requiring fluid management outside the clinical standard of care\n* congenital heart disease not including patent ductus arteriosus (PDA)","8 Days",{"count":399,"type":23},750,[59],"The aim of this study is to determine whether restricted fluid intake (135 ±5 mL\u002Fkg\u002Fday) compared to liberal fluid intake (165 ±5 mL\u002Fkg\u002Fday) from day 8 of life reduces the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age or prior death in preterm infants born \\\u003C30 weeks gestational age.",[29],[404,405],"Fluid Restriction","Preterm Infants","2026-05-04",{"date":408,"type":38},"2026-05-08",{"date":410,"type":38},"2025-07-12",{"date":412,"type":23},"2029-12",{"name":414,"class":45},"University Children's Hospital Basel",9,{"id":417,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":418,"targetDuration":4,"studyType":24,"phases":419,"briefSummary":27,"conditions":420,"keywords":421,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":428,"locationsCount":46},"100586443",{"count":22,"type":23},[26],[29,30],[32,33],"2026-04-29",{"date":424,"type":38},"2026-05-05",{"date":426,"type":23},"2026-05-01",{"date":42,"type":23},{"name":44,"class":45},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":135,"sex":18,"minAge":188,"maxAge":346,"enrollmentInfo":436,"targetDuration":4,"studyType":24,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":46},"100636087","phase-2-effects-of-ivig-for-bpd-in-preterm-infant-born-at-28-weeks-and-below-100636087","NCT07561125","Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below","The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below","Inclusion Criteria:\n\n* Gestational age ≤ 28 weeks + 6 days\n* Admission within 24 hours after birth.\n* Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.\n\nClinical manifestations: Respiratory symptoms such as tachypnea (rapid breathing) and cyanosis, requiring respiratory support (including invasive, non-invasive, or oxygen therapy) to maintain oxygen saturation.\n\nChest X-ray: Findings include increased bilateral lung markings or ground-glass opacities, and diffuse increased density in both lungs. Other possible causes such as infection or heart disease should be ruled out.\n\n• A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.\n\nExclusion Criteria:\n\n* Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)\n* Chromosomal defects (e.g., trisomy 13, 18, 21)\n* Severe intracranial hemorrhage\n* Multiple organ failure\n* With severe lung infections\n* Other circumstances that the investigator determines are not suitable for participation in this study",{"count":437,"type":23},29,[26],"It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. Participants will received continuous infusion IVIG 1 g\u002Fkg\u002Fday for the first 2 days, 0.5 g\u002Fkg\u002Fday for next 3 days (total does 3.5 g\u002Fkg), repeatable if necessary.",[29],"2026-04-26",{"date":426,"type":38},{"date":444,"type":23},"2026-04",{"date":446,"type":23},"2029-09",{"name":359,"class":45},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":455,"enrollmentInfo":456,"targetDuration":458,"studyType":243,"phases":4,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":471,"locationsCount":46},"100633321","early-prediction-of-bronchopulmonary-dysplasia-in-preterm-infants-using-clinical-data-100633321","NCT07525167","Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data","Early Prediction of Bronchopulmonary Dysplasia Using Clinical Data From the First Three Postnatal Weeks in Preterm Infants: A Retrospective Study With Large Language Models","Inclusion Criteria:\n\n* Preterm infants born before 32 weeks of gestation or with birth weight \\\u003C1,500 grams\n* Admitted and followed in the Neonatal Intensive Care Unit (NICU) of Konya City Hospital\n* Availability of complete clinical data in hospital records\n* Documented bronchopulmonary dysplasia (BPD) outcome status\n\nExclusion Criteria:\n\n* Presence of major congenital anomalies\n* Incomplete or missing clinical data\n* Death shortly after birth with insufficient follow-up data to determine BPD status","28 Days",{"count":457,"type":23},108,"3 Weeks","Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data from the First Three Postnatal Weeks with Large Language Models: A Retrospective Study This retrospective, observational study aims to evaluate the early prediction of bronchopulmonary dysplasia (BPD) in preterm infants using clinical data from the first, second, and third postnatal weeks. The study includes infants born before 32 weeks of gestation or weighing less than 1,500 grams, followed at the Neonatal Intensive Care Unit of Konya City Hospital.\n\nThe study will compare the performance of different large language models (LLMs), including ChatGPT, Gemini, and Claude, in predicting BPD development. Clinical variables such as gestational age, birth weight, respiratory support, oxygen requirement, mechanical ventilation duration, and infection status will be used.\n\nPrimary outcome: Accuracy of BPD risk prediction by each AI model compared to actual clinical outcomes. Secondary outcomes: Sensitivity and specificity of predictions, weekly prediction performance, and comparative performance among AI models.\n\nThe results will provide insight into the potential clinical utility of AI-based approaches for early BPD risk assessment in preterm infants.",[29],[29,462,463,464],"Machine Learning","Artificial Intelligence","preterm infant","2026-04-12",{"date":467,"type":38},"2026-04-15",{"date":426,"type":23},{"date":470,"type":23},"2026-12-31",{"name":472,"class":45},"Konya City Hospital",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":135,"sex":18,"minAge":481,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","0 Years","20 Years",{"count":484,"type":23},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,29,504,505,506,507,508,509,510],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":513,"type":38},"2026-04-06",{"date":515,"type":38},"2020-03-05",{"date":517,"type":23},"2027-07",{"name":519,"class":45},"Duke University",51,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":397,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":46},"100561367","phase-1-inhaled-ciclesonide-study-in-preterm-infants-100561367","NCT06589245","Inhaled Ciclesonide Study in Preterm Infants","The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n* Viable Infants born between 23 0\u002F7 - 29 6\u002F7 gestation\n* Requiring invasive (through an endotracheal tube) mechanical ventilation\n* Between day of life 8 to 35.\n* Infants have not received dexamethasone for 120 hours\n* If receiving hydrocortisone, then receiving ≤ 1mg\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.\n* Infants receiving DEX therapy will be excluded.\n* We will exclude infants who have had ≥ 1 glucose level \\> 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (\\>95% centile for gestational age) in the 48 hours prior to study entry.\n* For small for gestational age, we will exclude infants with a birthweight \\\u003C 5% centile for gestational age.\n* Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.\n* Infants receiving or have received any dexamethasone in the prior 120 hours.\n* Infants receiving \\>1mg\u002Fkg\u002Fday of hydrocortisone.\n* Infants receiving any other inhaled or systemic steroid.","35 Days",{"count":271,"type":23},[193],"Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).",[29],"2026-03-26",{"date":535,"type":38},"2026-03-27",{"date":537,"type":38},"2025-09-16",{"date":539,"type":23},"2026-08-31",{"name":541,"class":45},"Venkatesh Sampath",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":550,"maxAge":136,"enrollmentInfo":551,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":553,"conditions":554,"keywords":559,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},"100578261","prospective-multicentre-mixed-methods-study-to-explore-extubation-practices-and-respiratory-outcomes-in-extremely-preterm-neonates-100578261","NCT06808997","Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.","Criteria and Reasons for Extubation and Non-extubation in Preterm Infants: A Mixed Methods Study Prospectively Exploring Extubation and Reintubation Practices in Extremely Preterm Infants, and Associated Respiratory Outcomes.","CERAINE","Inclusion Criteria:\n\n* Gestational age \\\u003C 28 weeks of gestation\n* Age at admission to the participating unit \\\u003C24 hours\n\nExclusion Criteria:\n\n* Parental opposition to their infant's clinical data collection\n* Participation in a research protocol with potential impact on extubation and\u002For duration of mechanical ventilation","1 Minute",{"count":552,"type":23},100,"The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation.\n\nKey research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life.\n\nPatient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and\u002For definitive weaning from any ventilatory support or supplemental oxygen.",[555,556,116,557,29,558],"PreTerm Neonate","Extubation Readiness","Respiratory Morbidity","Mechanical Ventilation",[560,561,562,283],"extremely preterm infants","extubation","mechanical ventilation","2026-03-11",{"date":565,"type":38},"2026-03-12",{"date":567,"type":38},"2025-02-17",{"date":569,"type":23},"2026-04-30",{"name":179,"class":45},31,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":81,"enrollmentInfo":579,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":580,"conditions":581,"keywords":582,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":46},"100560592","pressure-sensing-mattresses-and-mechanical-ventilation-weaning-in-neonatal-100560592","NCT06579157","Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal","The Association Between Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal","Inclusion Criteria:\n\n* Using invasive ventilation support with flow sensors or non-invasive ventilation support\n* The legal representative signs the informed consent form\n\nExclusion Criteria:\n\n* Refusal to participate in the study",{"count":57,"type":23},"This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.",[29],[583,584,585,586],"newborn","ballistocardiograph","pressure sensor","unobtrusive sensing","2026-02-25",{"date":589,"type":38},"2026-02-27",{"date":591,"type":38},"2024-11-10",{"date":593,"type":23},"2027-07-31",{"name":595,"class":45},"Fu Jen Catholic University",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":603,"enrollmentInfo":604,"targetDuration":4,"studyType":24,"phases":606,"briefSummary":607,"conditions":608,"keywords":613,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":633},"100624563","premabiom-metatranscriptomics-of-the-respiratory-microbiome-to-predict-the-occurrence-of-bronchopulmonary-dysplasia-in-preterm-infants-100624563","NCT07411261","PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants","PremaBiom","Inclusion Criteria:\n\n* Preterm infants with gestational age at birth lower than 32 gestational weeks and 6 days.\n* Hospital stay in one of the participant neonatal care units\n* Infants covered by the social security system of at least one of their parents\n* Whose parents have been informed about the study and agree to sign the informed consent form\n\nExclusion Criteria:\n\n* Palliative care only\n* Lack of parental consent\n* Parents who are minors or under legal protection (guardianship, conservatorship, judicial protection)\n* Parents who do not speak French","72 Hours",{"count":605,"type":23},270,[59],"The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are:\n\n* What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ?\n* Which environmental or health factors are involved in the maturation of the respiratory microbiome ?\n\nParticipants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.",[29,609,610,611,612],"Preterm Infant Development","Asthma Childhood","Bronchiolitis","Viral Respiratory Tract Infections",[614,283,615,616,617,618,619,620,621,622,623],"respiratory microbiome","Prematurity","asthma","bronchiolitis","inflammation","inate immunity","respiratory tract infections","dysbiosis","personalized medicine","metatranscriptomics","2026-02-11",{"date":626,"type":38},"2026-02-13",{"date":628,"type":23},"2026-03",{"date":630,"type":23},"2031-03",{"name":632,"class":45},"University Hospital, Caen",6,{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":46},"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":641,"type":23},80,"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)",[644,29,278],"Infant, Premature, Diseases","2026-01-19",{"date":647,"type":38},"2026-01-21",{"date":649,"type":38},"2020-02-06",{"date":123,"type":23},{"name":652,"class":45},"Winston Manimtim",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":135,"sex":18,"minAge":4,"maxAge":660,"enrollmentInfo":661,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":671,"locationsCount":46},"100336228","mri-in-bpd-subjects-100336228","NCT03657693","MRI in BPD Subjects","MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence","Inclusion Criteria:\n\n* any term age NICU patient\n\nExclusion Criteria:\n\n* \\- ECMO,\n* Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,\n* Suspected muscular dystrophy or neurologic disorder that may affect lung development.\n* Significant genetic or chromosomal abnormalities that may affect lung development\n* Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).\n* Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.","4 Months",{"count":662,"type":23},160,"The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)",[29],"2026-01-05",{"date":667,"type":38},"2026-01-07",{"date":669,"type":38},"2018-05-04",{"date":42,"type":23},{"name":672,"class":45},"Children's Hospital Medical Center, Cincinnati"]