[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-respiratory-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-respiratory-failure":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100630908","phase-2-dexmedetomidine-for-invasive-ventilation-in-the-neonate-100630908",false,"NCT07493785","Dexmedetomidine for Invasive Ventilation In the NEOnate","Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation","Above mentioned age limits (0 -10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).\n\nInclusion Criteria:\n\n* Neonates with a gestational age at birth \\\u003C 32 weeks of gestation and corrected gestational age \\\u003C 32 weeks postmenstrual age\n* Invasively ventilated with an expected or effective duration of ventilation \\> 24 hours at inclusion\n* Under mechanical ventilation since less than 72 hours at inclusion\n* With parental consent\n* Affiliated to or benefiting from a social security system\n\nExclusion Criteria:\n\n* Previous inclusion in this trial\n* Participation in another trial including analgesics or sedatives\n* Ongoing palliative care\n* Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours\n* Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg \\\u003C postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg\u002Fkg\u002Fmin, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml\u002Fkg) in the 6 previous hours\n* Pulmonary hypertension requiring pharmacological treatment\n* Heart rate \\\u003C100 bpm\n* Hepatic impairment defined as alanine aminotransferase level \\> 2 x normal upper limit\n* Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event\n* Hypersensitivity to the active substance or to any of the excipients contained in the medicine","ALL","10 Weeks",{"count":19,"type":20},246,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.\n\nAs opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.\n\nAlthough opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.\n\nDexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.\n\nThe investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.",[27,28,29,30,31],"Invasive Ventilation","Infant Pain","Infant Discomfort","Infant Neurodevelopment","Neonatal Respiratory Failure",[33,34,35,36,37,38,39,40],"Neonatology","Invasive mechanical ventilation","Analgesia","Dexmedetomidine","Neurodevelopment","Opioids","Pain","Withdrawal syndrome","NOT_YET_RECRUITING","2026-03-20",{"date":44,"type":45},"2026-03-25","ACTUAL",{"date":47,"type":20},"2026-06-01",{"date":49,"type":20},"2034-08-01",{"name":51,"class":52},"Centre Hospitalier Intercommunal Creteil","OTHER",12,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100622624","lung-ultrasound-guided-respiratory-management-in-infants-100622624","NCT07386041","Lung Ultrasound-Guided Respiratory Management in Infants","Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial","NeoLUS-RCT","Inclusion Criteria:\n\n* Infants admitted to the Tufts Medical Center NICU\n* Requiring invasive or non-invasive respiratory support\n* Requiring surfactant therapy\n* Parental or guardian informed consent obtained\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Known chromosomal abnormalities\n* Congenital diaphragmatic hernia\n* Decision for comfort care\n* Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)",true,"0 Years","1 Year",{"count":66,"type":20},64,[68],"NA","This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support.\n\nThe primary outcome measure is length of NICU stay.",[31],"2026-01-26",{"date":73,"type":45},"2026-02-04",{"date":75,"type":20},"2026-08-01",{"date":77,"type":20},"2029-02-01",{"name":79,"class":52},"Tufts Medical Center",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100525546","flow-and-grow---the-ideal-time-to-wean-cpap-off-in-extremely-low-birth-weight-infants-100525546","NCT06123143","Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants","Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study","Flow&Grow","Inclusion Criteria:\n\n1. All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at \\\u003C 30 weeks CGA\n2. Informed parental consent obtained\n\nExclusion Criteria:\n\n1. Declined or unable to give informed consent\n2. Infants with known congenital anomalies or complications that require long term support (pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), anything surgical)\n3. Intubated for over 4 weeks of life (28 days)","30 Weeks",{"count":90,"type":20},130,[68],"Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange. While non-invasive respiratory support (NIS) can be gradually reduced over time as the infant grows, most weaning strategies often lead to weaning failure. This failure is evidenced by an increase in significant events such as apneas, desaturations, and\u002For bradycardias, increased work of breathing, or an inability to oxygenate or ventilate, resulting in escalated respiratory support. Although the optimal approach to weaning NIS remains uncertain, neonatal units that delay Continuous Positive Airway Pressure (CPAP) weaning until 32-34 weeks corrected gestational age exhibit lower rates of chronic lung disease. Therefore, the investigators aim to compare the duration on respiratory support and oxygen exposure in infants born at less than 30 weeks' gestational age who undergo a structured weaning protocol that includes remaining on CPAP until at least 32-34 weeks corrected gestational age (CGA). The hypothesis posits that preterm infants following a structured weaning protocol, including maintaining CPAP until a specific gestational age, will demonstrate lower rates of weaning failure off CPAP (defined as requiring more support and\u002For experiencing increased stimulation events 72 hours after CPAP weaning) than those managed according to the medical team's discretion.",[31],[95,96],"Neonatal","CPAP","RECRUITING","2026-01-15",{"date":100,"type":45},"2026-01-20",{"date":102,"type":45},"2023-11-27",{"date":104,"type":20},"2028-11",{"name":106,"class":52},"University of California, San Diego",5]