[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-distress-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,63,99,125,155,176,212,237,257,279,307,333,357,388,414,435,457,479,507,535,559,585],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100568680","phase-1-study-on-safety-and-efficacy-of-two-doses-of-prs-ck-storm-in-the-modulation-of-the-cytokine-storm-in-patients-with-acute-respiratory-infection-caused-by-sars-cov-2-influenza-a-influenza-b-and-respiratory-syncytial-virus-rsv-100568680",false,"NCT06684379","Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Double-blind, Randomized, Placebo-controlled, Pilot Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Two Doses of a Conditioned Medium From a Co-culture of M2-macrophages and Fat-derived Mesenchymal Cells (PRS CK STORM) in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Inclusion Criteria:\n\n1. Signed informed consent by the participant or legal representative prior to the initiation of any study-specific procedure.\n2. Males and females aged ≥ 18 years old at the time of the consent.\n3. Confirmed diagnosis of SARS-CoV-2, influenza virus A, influenza virus B or RSV pneumonia by positive RT-PCR (results of a PCR prior to screening will be valid only if the PCR has been done for all 4 viruses and in 3 days prior to the screening visit). PCR will include the analysis of SARS-Cov-2, influenza A, influenza B and RSV.\n4. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:\n\n   1. Body temperature over 38 ºC or under 36 ºC.\n   2. Heart rate greater than 90 beats\u002Fminute.\n   3. Respiratory rate higher than 20 breaths\u002Fmin or PaCO2 lower than 32 mmHg.\n   4. Leukocyte count higher than 12000\u002FμL, lower than 4000\u002FμL or over 10% immature forms or bands.\n5. Need for oxygen therapy.\n6. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \\[FSH\\] more than 20 international units \\[Ius\\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \\[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration.\n\nExclusion Criteria:\n\n1. Failure to perform screening or baseline examinations.\n2. Body Mass Index (BMI) more than or equal to 35.\n3. Irreversible critical condition, as assessed by the investigator.\n4. Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.\n5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:\n\n   1. Liver function test abnormalities or other signs of hepatic insufficiency not justified by a pulmonary acute inflammation process: Aspartate transaminase (AST), alanine transaminase (ALT) more than 3 per upper limit of the reference range, total bilirubin more than or equal to 2 mg\u002FdL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome.\n   2. Renal insufficiency (serum creatinine more than 2 mg\u002FdL (more than 150 μmol\u002FL) and creatinine clearance less than 30 (according to Cockcroft-Gault formula).\n   3. Myocardial infarction, unstable angina, heart failure within 3 months before screening.\n   4. Bradycardia (heartbeat less than 50\u002Fmin).\n   5. Atrioventricular block (type II \u002F Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males more than 450 msec and females more than 470 msec using Fridericia's formula: QTc = QT\u002F RR\\^2 ).\n   6. Uncontrolled diabetes mellitus (blood glucose level above 500 mg\u002FdL) at the time of admission.\n   7. Malignant tumors within the last 5 years, unless stable during that time. Skin malignancies (other than melanoma) and indolent prostate cancer are excluded from this criterion.\n   8. Metastases.\n   9. Human Immunodeficiency Virus (HIV), HBV \\[hepatitis B surface antigen (HBs Ag) positive (+), or detected sensitivity on the HBV deoxyribonucleic acid (DNA), polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBc Ab) positive subjects\\] or HCV \\[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\\].\n6. Inability to comply with the study and monitoring procedures.\n7. Pregnant and breastfeeding females (pregnancy test positive).\n8. Suspected or known active drug or alcohol abuse.\n9. Enrollment in another investigational drug study within 1 month before the screening\n10. Subject who has any condition, including any psychological or psychiatric condition, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy.\n\nThe main questions it aims to answer are:\n\n* Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n* Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group?\n* What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n\nResearchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.",[27,28,29,30,31],"SARS-CoV-2","Influenza, Human","Respiratory Syncytial Virus Infections","Respiratory Distress Syndrome","Systemic Inflammatory Response Syndrome",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,31],"SARS-CoV-2 infection","Causing atypical respiratory disease (COVID-19)","2019 Novel Coronavirus","COVID-19 Virus","SARS Coronavirus 2","COVID-19-associated cytokine storm","Lung Diseases","Pneumonia","M2-macrophages","Mesenchymal cells","Influenza A Virus","Influenza B Virus","RSV Infection","Acute Respiratory Distress Syndrome","ARDS, Human","Respiratory Distress Syndrome, Acute","Cytokine storm","RECRUITING","2026-06-05",{"date":53,"type":54},"2026-06-10","ACTUAL",{"date":56,"type":54},"2024-10-02",{"date":58,"type":20},"2026-10-02",{"name":60,"class":61},"PEACHES BIOTECH","INDUSTRY",3,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"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",{"count":73,"type":20},30,[23],"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.",[77,78,79,30,80],"Preterm Labor With Preterm Delivery","Premature Birth","Apnea of Prematurity","Bronchopulmonary Dysplasia",[82,83,84,85,86,87],"caffeine","preterm labor","prematurity","pharmacokinetics","bronchopulmonary dysplasia","apnea of prematurity","2026-06-03",{"date":90,"type":54},"2026-06-04",{"date":92,"type":54},"2026-06-01",{"date":94,"type":20},"2027-06",{"name":96,"class":97},"Indiana University","OTHER",1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":98},"100637589","effect-of-postural-drainage-with-or-without-thoracic-squeezing-on-o2-and-respiratory-rate-in-infant-with-rds-100637589","NCT07579013","Effect of Postural Drainage With or Without Thoracic Squeezing on O2 and Respiratory Rate in Infant With RDS.","Immediate Effects of Postural Drainage With or Without Thoracic Squeezing on Oxygen Saturation and Respiratory Rate in Children With Respiratory Distress Syndrome.","Inclusion Criteria:\n\n* ● Children diagnosed with RDS.\n\n  * Pre term infants. Birth history with c- section.\n  * No congenital malformation.\n\nExclusion Criteria:\n\n* ● Under treatment with neurotropic drugs.\n\n  * Respiratory and cardiac congenital anamolies.\n  * Genetic disorder.\n  * Interventricular hemorrhage or seizures.","1 Month","2 Months",{"count":109,"type":20},14,[111],"NA","This study investigated whether adding thoracic squeezing to postural drainage improves immediate respiratory outcomes in preterm infants with Respiratory Distress Syndrome (RDS).\n\nOver nine months, 14 preterm infants (all born via cesarean section) were randomly assigned to two groups. The control group received standard care with postural drainage, while the experimental group received postural drainage combined with the lung squeezing technique (LST), which applies gentle chest pressure to enhance airflow and mucus clearance. Infants with genetic disorders, congenital anomalies, or on neurotropic drugs were excluded.\n\nOxygen saturation and respiratory distress were measured using the Oxygen Saturation Index and Silverman-Anderson Scale, with data analyzed in SPSS.\n\nThe study aimed to determine whether combining thoracic squeezing with postural drainage has a greater immediate effect on improving oxygen levels and reducing respiratory distress compared to postural drainage alone.",[30],[115],"RDS, Postural drainage, Thoracic squeezing, O2","2026-05-05",{"date":118,"type":54},"2026-05-11",{"date":120,"type":54},"2025-10-28",{"date":122,"type":20},"2026-08-06",{"name":124,"class":97},"Riphah International University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100575784","phase-3-safety-and-efficacy-of-apc-0101-in-preterm-infants-with-respiratory-distress-syndrome-100575784","NCT06776783","Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome","A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome","Inclusion Criteria:\n\n1. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)\n2. Gestational age at birth of 26 through 33 weeks PMA\n3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)\n4. Birth weight ≤ 2000 grams\n5. Post-natal age 1 to 24 hours at randomization\n6. On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).\n7. FiO2 ≥ 0.24 at randomization\n8. nCPAP or mPaw ≥ 6 cm H2O at randomization\n9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization\n\nExclusion Criteria:\n\n1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\\> 2 liters per minute \\[LPM\\]) at the time of randomization\n2. Prior instillation of surfactant\n3. Premature rupture of membranes (PROM) occurring \\> 14 days before birth\n4. Significant congenital\u002Fchromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)\n5. Pneumothorax\n6. Other etiologies of respiratory distress\n7. Enrollment in another interventional study with similar efficacy endpoints\n8. Apgar score at 5 min of 0-3\n9. Prior cardiopulmonary resuscitation (CPR) or epinephrine\n10. Base Deficit \\> 15 mEq\u002FL on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.\n11. Partial pressure of carbon dioxide (PaCO2) \\> 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.\n12. Triplet or higher order multiple birth","1 Hour","24 Hours",{"count":135,"type":20},520,[137],"PHASE3","This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP\u002FNIV to subjects treated with nCPAP\u002FNIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.",[30,140],"Pre-term Infants",[142,143,144],"respiratory distress syndrome","surfactant","pre-term infant","2026-04-13",{"date":147,"type":54},"2026-04-14",{"date":149,"type":54},"2025-09-24",{"date":151,"type":20},"2029-05",{"name":153,"class":61},"Aerogen Pharma Limited",12,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":98},"100626573","effect-of-l-carnitine-supplementation-in-preterm-neonates-100626573","NCT07437391","Effect of L-Carnitine Supplementation in Preterm Neonates","Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)","Inclusion Criteria:\n\n* Preterm neonates\n* Either gender\n* With RDS\n* Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .\n\nExclusion Criteria:\n\n* Neonates with gastrointestinal tract (GIT) anomalies\n* With confirmed or suspected sepsis at the time of enrollment\n* Neonates whose clinical condition contraindicates study participation (e.g., expected survival \\\u003C48 hours, as judged by the neonatologist).",{"count":163,"type":20},160,[111],"The current study is planned to see the effect of L-carnitine supplementation in preterm neonates suffering from RDS among the local population, as there is no such evidence available for the local population and there are conflicting statistics regarding the discharge rate of these neonates.",[30],"2026-02-23",{"date":169,"type":54},"2026-02-27",{"date":171,"type":54},"2026-01-01",{"date":173,"type":20},"2026-06-30",{"name":175,"class":97},"Muhammad Aamir Latif",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":196,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":98},"100557114","percutaneous-cryoablation-of-intercostal-nerves-for-the-treatment-of-rib-fractures-100557114","NCT06533904","Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures","Inclusion Criteria:\n\n* \\> 18 years old\n* \\> 2 rib fractures\n* Verbal Pain score \\> 5\n* Incentive Spirometry \\\u003C 60% of predicted\n\nExclusion Criteria:\n\n* Isolated Fractures of Ribs 1-3 and\u002For 10-12\n* Posterior Rib Fracture \\\u003C 4 cm from costovertebral joint\n* Sternal, Clavicle, Scapula Fracture\n* Thoracic Spinal Fracture of any type\n* Open Abdominothoracic Surgery\n* Unstable Spine\n* Extensive Subcutaneous Emphysema\n* BMI \\> 35\n* Plan for Rib Plating\n* Chronic Opioid Use\n* Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy\n* Coagulopathy, Shock at time of ablation\n* Inability to participate in activities of daily living prior to injury\n* Home O2 use prior to trauma\n* Inhalation Injury\n* Rib Fractures due to cardiopulmonary resuscitation\n* Life Expectancy \\\u003C 6 months\n* \\> 48 hours from injury\n* Pregnant, Incarcerated",true,"80 Years",{"count":73,"type":20},[111],"The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are:\n\nDoes percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium?\n\nResearchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery.\n\nParticipants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.",[188,189,190,191,192,193,194,195,30],"Trauma","Rib Fractures","Chest Wall Disorder","Respiratory Insufficiency","Pain, Chest","Rib Trauma","Rib Fracture Multiple","Respiratory Failure",[188,195,197,191,189,198,199,200,201],"Respiratory Distress","Chest Wall Trauma","Percutaneous Cryoablation","Multimodal Pain Therapy","Multimodal Pain Regimen","NOT_YET_RECRUITING","2026-02-05",{"date":205,"type":54},"2026-02-09",{"date":207,"type":20},"2026-09",{"date":209,"type":20},"2028-07",{"name":211,"class":97},"Loma Linda University",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":98},"100549172","personalized-ventilation-based-on-ventilation-perfusion-mismatch-and-lung-recruitability-100549172","NCT06430554","Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability","Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients","Inclusion Criteria:\n\n1. age ≥18 years\n2. Moderate-to-severe ARDS as per the 2023 ESICM definition\n3. Undergoing invasive mechanical ventilation\n4. Planned prone position based on the attending physicians' decisions\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. age ≥85 years\n2. Pregnancy\n3. Severe hemodynamic instability (\\> 30% increase in vasopressors in the last 6 hours or norepinephrine \\> 0.5 µg\u002Fkg\u002Fmin)\n4. Clinically suspected elevated intracranial pressure (\\>18 mm Hg)\n5. Bronchopleural fistula\n6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)\n7. Severe hypernatremia (\\>170mmol\u002FL)\n8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies","85 Years",{"count":221,"type":20},40,"OBSERVATIONAL","This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.",[30,225,226],"Positive-Pressure Respiration","Mechanical Ventilation",[228],"Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation\u002Fperfusion matching.","2026-01-29",{"date":231,"type":54},"2026-02-03",{"date":233,"type":54},"2024-06-08",{"date":173,"type":20},{"name":236,"class":97},"Zhongda Hospital",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":98},"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":244,"type":20},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)",[247,80,30],"Infant, Premature, Diseases","2026-01-19",{"date":250,"type":54},"2026-01-21",{"date":252,"type":54},"2020-02-06",{"date":254,"type":20},"2027-12-31",{"name":256,"class":97},"Winston Manimtim",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":98},"100614962","nebulized-furosemide-heparin-hypertonic-saline-in-mechanically-ventilated-acute-respiratory-distress-syndrome-adult-patients-100614962","NCT07286409","Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients","Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* ICU admission, mechanical ventilation for \\\u003C 7 days\n* ARDS diagnosed within 24 hours per the Berlin Definition, which includes Chest x-ray showing bilateral opacities, not fully explained by effusions, lung collapse; Respiratory failure not fully explained by cardiac failure or fluid overload, and exclusion of hydrostatic edema (by echocardiography);\n* Oxygenation and ventilator settings matching one of the three categories of ARDS: Mild: 200 mmHg \\\u003C PaO2\u002FFIO2 ≤ 300 mmHg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥ 5 cm H2O. Moderate: 100 mm Hg \\\u003C PaO2\u002FFIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O. Severe: PaO2\u002FFIO2 ≤ 100 mm Hg with PEEP ≥ 5 cm H2O.\n\nExclusion Criteria:\n\n* 1- Pregnant Patient. 2- Refusal to participate in the trial by the patient's guardian. 3- Known allergy to furosemide or heparin. 4- Active major bleeding, recent intracranial hemorrhage 5- End-stage renal disease 6- Severe chronic liver disease. 7- Uncontrolled shock (e.g., high vasopressor doses). 8- Advanced directives limiting care (e.g., do-not-resuscitate orders), which could affect mortality outcomes.\n\n  9- Body Mass Index (BMI) \\> 40 or severe obesity, which can severely impact lung mechanics and confound results.\n\n  10- Electrolyte imbalance",{"count":265,"type":20},344,[111],"There are no specific drugs or therapies available to directly treat\u002Fprevent ARDS. Mechanical ventilation with an aim to minimize Ventilator Induced Lung Injury (VILI) and management of refractory hypoxemia are the keystones in supportive management of ARDS.",[30,269],"Mechanical Ventilation Complication","2025-12-02",{"date":272,"type":54},"2025-12-16",{"date":274,"type":20},"2026-01",{"date":276,"type":20},"2027-01",{"name":278,"class":97},"Tanta University",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":98},"100578183","lung-and-cardiac-ultrasound-for-respiratory-distress-in-elderly-100578183","NCT06807983","LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly","Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography","LUCREED","Inclusion Criteria:\n\nEligible patients will be aged over 65 years, affiliated with the French social security system, and presenting to the ED with acute dyspnea (onset \\\u003C14 days) accompanied by severity signs before or at triage (respiratory rate ≥22 and SpO2 \\\u003C92% on room air). The enrolling emergency physician (EP) must be the patient's treating physician and must be trained in LuCUS. Written informed consent from the patient or their legal representative is required for inclusion\n\nExclusion Criteria:\n\ndyspnea secondary to thoracic trauma, dyspnea clearly related to COVID-19, known pulmonary fibrosis or lung cancer, prior administration of specific treatment for dyspnea before inclusion, immediate need for endotracheal intubation, patients identified as being at end-of-life, and individuals under legal guardianship or deprived of liberty.","65 Years",{"count":289,"type":20},504,[111],"Prospective trial to evaluate the impact on the initial therapeutic inadequacy of a management strategy for acute dyspnea in the elderly based on the use of lung and cardiac ultrasonography.",[293,30],"Dyspnea",[295,296,297,293],"Elderly","Point-of-Care Ultrasound","Respiratory Distress Syndrom","2025-11-26",{"date":300,"type":54},"2025-12-04",{"date":302,"type":54},"2025-11-04",{"date":304,"type":20},"2027-05-01",{"name":306,"class":97},"University Hospital, Toulouse",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":98},"100563956","influence-of-flow-rate-change-on-co2-levels-during-high-flow-nasal-ventilation-hfnv-in-preterm-infants-100563956","NCT06622902","Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.","Inclusion criteria:\n\n* Gestational age 240 to 336.\n* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).\n* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.\n* At least 6 hours from surfactant administration.\n* Parental consent\n\nExclusion criteria:\n\n* If flow is \\<3 and tcCO2 related pCO2 is\\<40mmHg.\n* If Flow is ≥5 bpm and tcCO2 related pCO2 is\\>60mmHg.\n* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.",{"count":314,"type":20},45,[111],"Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.\n\nAim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.\n\nMethods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.\n\nOutcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.\n\nStatistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.",[30,318,319],"Prematurity","Non Invasive Ventilation",[321,84,322,323,324],"Respiratory distress syndrome","HIGH FLOW","CO2","VENTILATION",{"date":326,"type":54},"2025-11-28",{"date":328,"type":54},"2023-08-16",{"date":330,"type":20},"2026-12-31",{"name":332,"class":97},"Rambam Health Care Campus",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":98},"100604793","endocan-and-copeptin-serum-levels-in-preterm-neonates-with-respiratory-distress-syndrome-100604793","NCT07154134","Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome","Comparative Study Between Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Prematurity.\n* Gestational age between 28 and 36 weeks.\n* Suffering from respiratory distress syndrome.\n\nExclusion Criteria:\n\n* Intrauterine growth restriction (IUGR).\n* Hypoxic ischemic encephalopathy.\n* Multiple congenital anomalies.\n* Chromosomal abnormalities.\n* Preterm less than 28 weeks.\n* Neonates with a maternal history of chorioamnionitis (early sepsis).\n* Infant of diabetic mother.\n* Prelabor rupture of membranes (PROM)\\> 2 hours.","28 Weeks","36 Weeks",{"count":221,"type":20},"This work aims to investigate and compare the levels of serum endocan and serum copeptin on the first day of life and correlate their levels to the severity of respiratory distress in preterm neonates suffering from respiratory distress syndrome.",[345,346,347,348,30],"Endocan","Copeptin","Serum","Preterm Neonates","2025-08-27",{"date":351,"type":54},"2025-09-04",{"date":353,"type":54},"2025-07-10",{"date":355,"type":20},"2025-11-01",{"name":278,"class":97},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":385,"locationsCount":98},"100601672","post-extubation-use-ram-cannula-versus-short-binasal-prong-interfaces-in-preterm-infants-100601672","NCT07113535","Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants","RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Inborn preterm neonates ≤ 32 weeks of gestational and\u002For birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.\n\nExclusion Criteria:\n\n* Outborn preterm neonates\n* Major congenital malformations.","28 Days",{"count":366,"type":20},90,[111],"Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.\n\nThe investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.\n\nThe investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.",[370,30,371],"Premature","Extubation",[373,374,375,376,377,378],"nasal interface","noninvasive respiratory support","premature","RAM cannula","Chest ultrasound","Diaphragm","2025-08-04",{"date":381,"type":54},"2025-08-08",{"date":383,"type":20},"2025-08",{"date":254,"type":20},{"name":386,"class":387},"Ministry of Health, Saudi Arabia","OTHER_GOV",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":98},"100521806","phase-4-non-inferiority-trial-investigating-surfactants-administered-via-mist-100521806","NCT06074380","Non Inferiority Trial Investigating Surfactants Administered Via MIST","Niftisurf","Inclusion Criteria:\n\n* Preterm infants 28-35 6\u002F7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30\n\nExclusion Criteria:\n\n* Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.\n* Infants who require emergent intubation will not be enrolled in the interventions.","48 Hours",{"count":397,"type":20},262,[399],"PHASE4","RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6\u002F7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.\n\nExclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.\n\nBabies who require emergent intubation will not be enrolled in the interventions.\n\nParental Consent will be obtained prior to randomization.",[30],[403,404,405],"Pulmonary Surfactant","CPAP","Neonate",{"date":407,"type":54},"2025-08-07",{"date":409,"type":54},"2024-01-01",{"date":411,"type":20},"2027-12-01",{"name":413,"class":97},"Endeavor Health",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":420,"maxAge":133,"enrollmentInfo":421,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":98},"100422202","surfactant-for-neonatal-respiratory-distress-syndromenrds-and-neonatal-acute-respiratory-distress-syndromenards-100422202","NCT04777760","Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)","Inclusion Criteria:\n\nEligibility requirements for neonates were as follows:\n\n* The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth\n* The neonates will be diagnosed with NRDS or NARDS\n* The neonates will be at least administrated one dose of surfactant\n\nExclusion Criteria:\n\none of the following criteria will be needed\n\n* major congenital anomalies\n* chromosomal abnormalities\n* upper respiratory tract abnormalities","1 Minute",{"count":422,"type":20},400,"In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and\u002For death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.\n\nIn 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.",[30,425,46,426],"Preterm Birth","Surfactant Dysfunction","2025-06-26",{"date":429,"type":54},"2025-07-01",{"date":431,"type":54},"2021-01-01",{"date":330,"type":20},{"name":434,"class":97},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":71,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":98},"100583296","respiratory-distress-and-elective-cesarean-section-at-term-100583296","NCT06874478","Respiratory Distress and Elective Cesarean Section at Term","The Rate and Predictors of Respiratory Distress Among Neonates Delivered by Elective Cesarean Section at Term","Inclusion Criteria:\n\n1. Maternal age of 20-39 years.\n2. Women with singleton pregnancy ≥ 37 weeks\n3. Pregnant women who received corticosteroid to enhance lung maturity and will be subjected to elective cesarian section (before onset of labour) within 1 week after administration of corticosteroid\n\nExclusion Criteria:\n\n1. Women with oligohydramnios or polyhydramnios.\n2. Women with underlying disease requiring corticosteroids.\n3. Pregnant women with any medical disorders such as hypertension, diabetes, renal diseases, antiphospholipid syndrome, intrauterine growth restriction, preterm premature rupture of membrane, placenta previa, antepartum haemorrhage, on anticoagulant thereby.\n4. Women with confirmed fetal malformation.\n5. Women who will refuse to participate.","20 Years","39 Years",{"count":445,"type":20},210,"Cesarean section is a life-saving surgical operation for women and their newborns. In Egypt, caesarean sections are over-utilized. The rate increased from 27.6 % in 2008 to 51.8 % in 2014, reaching 72.2 % in 2021. Cesarean section has been associated with an increased risk of adverse respiratory outcomes in newborns. Studies have shown a higher risk of neonatal respiratory distress syndrome in babies born by elective cesarean section, especially at 37 and 38 weeks' gestation. Neonatal respiratory distress syndrome is one of the leading causes of neonatal morbidity and mortality. Many non-invasive tools have been used to predict the risk of neonatal respiratory distress syndrome. Most of these studies assessed the predictors of neonatal respiratory distress syndrome in low birth or preterm fetuses, and none of them talked about neonatal respiratory distress syndrome with term fetuses. Doppler velocimetry provides a simple and non-invasive method to assess the fetal pulmonary circulation. Pulmonary Doppler velocimetry is used to determine lung maturity in complicated pregnancies. The magnitude of neonatal respiratory distress syndrome among term neonates depends on the availability of medical services and the number of trained medical personnel. So, there is a need to assess the rate and predictors of eonatal respiratory distress syndrome among low-risk term fetuses delivered by Cesarean section to give attention and appropriate intervention for these predictors to decrease the morbidity and mortality associated with eonatal respiratory distress syndrome.",[30],"2025-05-22",{"date":450,"type":54},"2025-05-28",{"date":452,"type":54},"2025-05-01",{"date":454,"type":20},"2027-12",{"name":456,"class":97},"Assiut University",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":21,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":98},"100510562","spinal-cord-stimulation-to-shorten-ventilator-dependence-in-ards-patients-100510562","NCT05928052","Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients","Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS","Inclusion Criteria:\n\n1. Male or female 18-85 years;\n2. Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and\u002For nodules, respiratory failure not explained by heart failure or fluid overload, PaO2\u002FFiO2 ratio \\\u003C 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;\n3. Able to provide informed consent or available next of kin able to provide informed consent;\n4. Have intact chest\u002Flung, upper and lower extremity anatomy;\n5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;\n6. Enrollment of subject within 48 hours of intubation;\n7. Able to induce evoked response of diaphragm muscle by spinal cord TES.\n\nExclusion Criteria:\n\n1. Phrenic nerve or diaphragm pacer;\n2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;\n3. Compromised skin in back (neck, upper and lower back);\n4. Pregnancy;\n5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;\n6. BMI greater than or equal to 35;\n7. Pharmacological paralysis\u002Fneuromuscular blockade\\*.",{"count":465,"type":20},20,[111],"This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.",[30],[30],"2025-03-07",{"date":472,"type":54},"2025-03-10",{"date":474,"type":54},"2023-04-18",{"date":476,"type":20},"2029-01-06",{"name":478,"class":97},"University of California, Los Angeles",{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":16,"minAge":487,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"100509038","effects-of-flow-magnitude-on-cardiorespiratory-stability-during-nasal-high-flow-therapy-in-preterm-infants-100509038","NCT05908227","Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants","Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)","MASTER","Inclusion Criteria:\n\nInclusion if all apply.\n\n* Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)\n* \\>2nd day of life (defined as date day)\n* Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:\n\n  * ≤ 2 apneas with concomitant bradycardias (\\\u003C100\u002Fmin) per hour for the previous 6 hours\n  * FiO2 ≤ 0.3 and not increasing\n  * No significant chest recessions (Silverman Score \\\u003C 5)\n  * Respiratory rate ≤ 60\u002Fmin\n  * No need for intermittent positive pressure ventilation\n* Parents with an age 18+ years\n* Written parental informed consent (or other legal representative)\n\nExclusion Criteria:\n\nExclusion if any applies.\n\n* Significant fetal anomalies\n* Primary palliative care\n* Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours","23 Weeks","31 Weeks",{"count":490,"type":20},150,[111],"Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.",[30],[495,496],"Nasal high flow therapy","Continuous positive airway pressure","2025-02-19",{"date":499,"type":54},"2025-02-21",{"date":501,"type":54},"2023-07-01",{"date":503,"type":20},"2026-02",{"name":505,"class":97},"Insel Gruppe AG, University Hospital Bern",2,{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":21,"phases":517,"briefSummary":518,"conditions":519,"keywords":522,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":4},"100539829","phase-2-mrg-001-as-an-immunoregulatory-and-regenerative-therapy-for-ards-patients-100539829","NCT06308926","MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients","A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome","SUMMIT","Inclusion Criteria:\n\nAcute Respiratory Distress Syndrome, manifested by the following and not explained by alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive Heart Failure (CHF).\n\n1. Chest x-ray (CXR)\\* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.\n2. PaO2\u002FFiO2 \\\u003C 300.\n3. Requiring respiratory support \\[defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)\\] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.\n\nExclusion Criteria:\n\n1. Age less than 18 years.\n2. Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of \\\u003C 18 for \\>12 hours would rule out suspected CHF).\n3. Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.\n4. Immunocompromised patients:\n\n   4.1. Organ or bone marrow transplant recipients and\u002For recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1\u002F2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).\n\n   4.2. Patients with documented or suspected HIV\u002FAIDS, hepatitis B\u002FC or active lung disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of chemotherapy in the past 3 months.\n5. Hypersensitivity to either of the components of MRG-001.\n6. The patient is known or suspected to be brain dead or is moribund (not expected to live \\>48 hours) or is unlikely to survive long enough to receive 3 injections (4 days) in the opinion of the investigator.\n7. The primary care physician is not committed to full support of the patient. (A DNR representing \"no chest compression\" only, would not necessarily be an exclusion. A DNR in which life support is withheld\u002Fwithdrawn or is otherwise limited, would be an exclusion).\n8. Participation in another investigational protocol or use of another investigational drug within 30 days of enrollment.\n9. Enrollment time window has been exceeded (must be enrolled within 7 days of hospital admission and within 48 hours of development of ARDS).\n10. Significant pre-existing organ dysfunction prior to randomization:\n\n    10.1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record. 10.2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg. WHO Class III or IV pulmonary hypertension. 10.3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR \\\u003C30 mL\u002Fmin. 10.4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or pre-existing severe hepatic dysfunction (i.e.; portal hypertension, cirrhosis, ascites, esophageal variceal bleeding, acute hepatic necrosis). 10.5. Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL. 10.6. Neurological: Severe traumatic brain injury, with intracranial injury demonstrated by head CT 10.7. History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n11. Currently receiving extracorporeal life support (ECLS\u002FECMO) or high-frequency oscillatory ventilation (HFOV).\n12. Anticipated extubation within 24 hours of enrollment.",{"count":516,"type":20},60,[24],"This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.\n\nThe aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.",[46,195,30,520,521],"Respiratory Tract Diseases","Cytokine Storm",[46,523,524,525],"MRG-001","Stem Cells","Immunomodulation","2024-08-22",{"date":528,"type":54},"2024-08-23",{"date":530,"type":20},"2024-12-01",{"date":532,"type":20},"2026-07-01",{"name":534,"class":61},"MedRegen LLC",{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":4},"100558541","post-extubation-pressures-in-preterm-neonates-a-cer-study-100558541","NCT06552455","Post-extubation Pressures in Preterm Neonates: A CER Study","Post-extubation Pressures on Non-invasive Respiratory Support in Preterm Neonates: A Prospective Comparative Effectiveness Research Study","Inclusion Criteria:\n\n* Preterm neonates GA \\\u003C28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.\n\nExclusion Criteria:\n\n* Major chromosomal\u002Fgenetic\u002Fcongenital abnormalities\n* Never received invasive mechanical ventilation (IMV)\n* Received IMV, but never extubated to non-invasive respiratory support (NRS)\n\n  * Transferred to non-participating site while intubated\n  * Death prior to extubation\n  * Initial extubation was for withdrawal of care\n* Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.",{"count":543,"type":20},1050,"The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown.\n\nThe investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations.\n\nThis will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal\u002FLower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients \\\u003C28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure \\\u003C\u002F= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.",[30,80,425],[547,548,318,549],"Extubation Failure","Non-invasive respiratory support","Post-extubation pressures","2024-08-09",{"date":552,"type":54},"2024-08-14",{"date":554,"type":20},"2024-11-01",{"date":556,"type":20},"2028-12-31",{"name":558,"class":97},"McMaster Children's Hospital",{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":16,"minAge":566,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":98},"100518498","the-role-of-lung-ultrasonography-score-in-predicting-prognosis-in-term-and-late-preterm-newborns-with-postnatal-respiratory-distress-100518498","NCT06031324","The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress","TeLaPLUS","Inclusion Criteria:\n\n* Having symptoms of respiratory distress that begin soon after birth,\n* \\> 34 gestational age,\n* \\>1900 gr birth weight,\n* Family consent\n\nExclusion Criteria:\n\n* Congenital anomaly\n* Chromosomal anomaly\n* Hydrops fetalis\n* Congenital heart disease","30 Minutes","120 Minutes",{"count":569,"type":20},100,"Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.",[30,572],"Lung Ultrasonography Score",[321,574,575],"Lung ultrasonography","Newborn","2024-07-12",{"date":578,"type":54},"2024-07-15",{"date":580,"type":54},"2023-11-11",{"date":582,"type":20},"2025-02-28",{"name":584,"class":387},"Bursa City Hospital",{"id":586,"slug":587,"hasResults":11,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":11,"sex":16,"minAge":592,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":21,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":607,"locationsCount":4},"100548477","less-invasive-surfactant-administration-in-late-preterm-or-early-term-born-infants-100548477","NCT06421506","Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants","Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?","Inclusion Criteria:\n\n* Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.\n* Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.\n\nExclusion Criteria:\n\n* Infants requiring intubation at birth\n* Infants with severe congenital anomalies.","34 Weeks","38 Weeks",{"count":595,"type":20},245,[111],"The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.\n\nLess invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.\n\nHigh flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.\n\nThe investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.\n\nThe investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.",[30,599,600],"Preterm Pregnancy","Surfactant Deficiency Syndrome Neonatal","2024-05-21",{"date":603,"type":54},"2024-05-22",{"date":605,"type":20},"2024-05",{"date":207,"type":20},{"name":608,"class":97},"King's College Hospital NHS Trust"]