[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rds-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rds-of-prematurity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100558699","phase-4-pragmatic-evaluation-of-respiratory-distress-syndrome-treatment-in-africa-100558699",false,"NCT06554522","Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa","Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa","Inclusion Criteria:\n\n* Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.\n* Silverman Anderson Score ≥5 before or after CPAP treatment.\n* Admitted to a study site within 24 hours of life.\n\nExclusion Criteria:\n\n* Major congenital or genetic anomalies.\n* Active pulmonary hemorrhage.\n* Major craniofacial anomalies that preclude the successful use of CPAP","ALL","1 Hour","24 Hours",{"count":20,"type":21},1512,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:\n\nDoes surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?\n\nResearchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.\n\nParticipants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:\n\nReceive surfactant replacement therapy by the less invasive surfactant administration technique.\n\nBe monitored for complications Be followed throughout their hospitalization to determine their survival rate.",[27,28,29,30],"Respiratory Distress Syndrome in Premature Infant","RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","Premature Birth","RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2025-01-01",{"date":39,"type":21},"2027-12-30",{"name":41,"class":42},"Indiana University","OTHER",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100597624","pivotal-study-to-assess-safety-and-performance-of-neola-a-novel-lung-monitoring-device-for-neonates-100597624","NCT07060911","Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates","IInclusion criteria:\n\n* Preterm or term born neonates with gestational age between 26 and 40 weeks\n* Age between 1 day post-natal and 44 weeks corrected gestational age\n* Weight between 1000 g and 3500 g\n* Patient treated at a neonatal intensive care unit.\n* Patient is either on invasive mechanical ventilation, on CPAP or NIPPV or receives respiratory support via high-flow nasal cannula (≥2L\u002Fmin)\n* Signed informed consent prior to any study related procedures by the legal representatives of the patient\n\nExclusion criteria:\n\n* Known cardiopulmonary congenital anomalies\n* Patients with trisomies or other chromosomal abnormality\n* Patients not expected to survive\n* Non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., Bullous impetigo, Staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus)\n* Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.","1 Day","44 Weeks",{"count":53,"type":21},22,[55],"NA","Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates",[28,58,59],"Preterm Birth","Lung Diseases",[61,62,63],"GASMAS","Spectroscopy","Gas absorption spectroscopy","NOT_YET_RECRUITING","2025-07-02",{"date":67,"type":35},"2025-07-11",{"date":69,"type":21},"2026-03",{"date":71,"type":21},"2027-02",{"name":73,"class":74},"Neola Medical Inc","INDUSTRY",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100396704","surfactant-administration-by-insure-or-thin-catheter-100396704","NCT04445571","Surfactant Administration by Insure or Thin Catheter","SAINT","Inclusion Criteria:\n\n* Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.\n\nExclusion Criteria:\n\n* Infants requiring surfactant as part of delivery room resuscitation are not eligible.\n\nInfants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.","2 Days",{"count":85,"type":21},160,[55],"This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.",[28,29,89],"Analgesia",[91,92,93],"LISA (Less invasive surfactant administration)","INSURE","CPAP","2025-06-26",{"date":96,"type":35},"2025-07-01",{"date":98,"type":35},"2021-05-21",{"date":100,"type":21},"2026-12-31",{"name":102,"class":42},"Karolinska Institutet",1]