[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"positive-pressure-ventilation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:positive-pressure-ventilation":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100598472","phase-2-a-clinical-trial-of-early-ventilation-in-amyotrophic-lateral-sclerosis-event-als-100598472",false,"NCT07071935","A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","A Pilot Randomized Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","EVENT ALS","Inclusion Criteria:\n\n* Diagnosed with ALS using the Gold Coast Criteria within the last 6 months\n* Age ≥18 years\n* Willingness and ability to participate in study procedures\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Current or prior or recommended\u002Fprescribed use of NIV including:\n\n   i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or \"CPAP\" therapy\n2. Forced vital capacity \\\u003C50% of predicted normal\n3. Maximal inspiratory pressure \\> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)\n4. Chronic use of supplemental oxygen at any part of the day\n5. Enrollment in hospice\n6. Current tracheostomy\n7. Prior history of sleep apnea where non-invasive ventilation was used or recommended\n8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks\n9. Coughing up blood\n10. Myocardial infarction in the previous 4 weeks\n11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)\n12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time.\n\nThe investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day.\n\nIn this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study.\n\nThe purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.",[27,28,29,30,31,32,33,34,35,36],"Amyotrophic Lateral Sclerosis (ALS)","Chronic Respiratory Failure","Neuromuscular Disease Patients","Neuromuscular Disease","Respiratory Insufficiency","Respiratory Insufficiency Requiring Mechanical Ventilation","Positive Pressure Ventilation","Non-invasive Ventilation","Non-invasive Ventilation Support","Non-invasive Ventilatory Support",[38,39,40,41],"chronic respiratory failure","chronic neuromuscular respiratory failure","non-invasive ventilation","amyotrophic lateral sclerosis","RECRUITING","2026-06-25",{"date":45,"type":46},"2026-06-26","ACTUAL",{"date":48,"type":46},"2026-06-11",{"date":50,"type":21},"2029-05",{"name":52,"class":53},"University of Pennsylvania","OTHER",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":77,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100625192","supraglottic-airway-for-resuscitation-in-preemies-100625192","NCT07419438","Supraglottic Airway for Resuscitation in Preemies","Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial","SUPREEMIE","Inclusion Criteria:\n\n* Gestational age 29 0\u002F7 to 33 6\u002F7 weeks at birth\n* Estimated fetal weight \\>\u002F= 1000 grams at birth\n* Clinical decision to initiate PPV\n* Parental informed consent\n\nExclusion Criteria:\n\n* Major anomalies or aneuploidy\n* Palliative care planned or considered\n* Not resuscitated in the infant resuscitation room","0 Days","1 Day",{"count":65,"type":21},20,[67],"NA","The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0\u002F7 and 33 6\u002F7 weeks' gestation who require PPV at birth.\n\nThe main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0\u002F7 to 33 6\u002F7 weeks' gestation premature infants?\n\nParticipants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.",[70,71,72,33,73,74,75,76],"Respiratory Failure","Premature Neonates","Delivery Room Resuscitation","Neonatal Resuscitation","Supraglottic Airway","Laryngeal Mask","Laryngeal Mask Airways",[78,79,72,80,81,74,82,76],"Respiratory failure","Premature neonates","Positive pressure ventilation","Neonatal resuscitation","laryngeal mask","2026-04-16",{"date":85,"type":46},"2026-04-17",{"date":87,"type":46},"2026-03-13",{"date":89,"type":21},"2026-10",{"name":52,"class":53},1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100604546","supraglottic-airway-for-resuscitation-trial-100604546","NCT07150923","Supraglottic Airway for Resuscitation Trial","Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation","SUGAR","Population 1: Hospital Staff\n\nPopulation 1a: Clinical providers and administrators who complete study questionnaires\n\nClinical provider 1a inclusion criteria:\n\n* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation\n* Fluent in English\n\nAdministrator 1a inclusion criteria\n\n* Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)\n* Fluent in English\n\nClinical provider and administrator exclusion 1a criteria: No exclusion criteria\n\nPopulation 1b: Clinical providers who participate in qualitative interviews\n\nClinical provider 1b inclusion criteria:\n\n* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation\n* Fluent in English\n\nClinical provider 1b exclusion criteria: No exclusion criteria\n\nPopulation 2: Patients who receive neonatal resuscitation at birth\n\nInclusion Criteria:\n\n* Inborn (not transferred to the hospital after birth)\n* ≥34 weeks' gestation at birth, based on best obstetrical estimate\n* Received PPV during neonatal resuscitation (as per provider's clinical assessment)\n\nExclusion Criteria:\n\n* Congenital diaphragmatic hernia\n* Airway anomalies",{"count":101,"type":21},36503,[67],"This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation, with a focus on implementation outcomes.",[73,72,33,105,74,76,106],"Infant, Newborn","Implementation Research",[73,72,80,74,76,106,105],"2026-02-26",{"date":110,"type":46},"2026-02-27",{"date":112,"type":46},"2026-01-01",{"date":114,"type":21},"2029-09",{"name":116,"class":53},"Children's Hospital of Philadelphia",30]