[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613805":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":31,"collaborators":20,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":9,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":20},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ENCP LISA","EXPERIMENTAL","Infants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L\u002Fmin) with FiO₂ titrated to maintain SpO₂ ≥92%. LISA catheter will be introduced under direct laryngoscopic vision 1-2 cm below the vocal cords. Two fractional boluses of surfactant (Curosurf, 200 mg\u002Fkg) will be administered within 2 minutes during ECNP support using Hayek RTX via a well-fitted thoracoabdominal cuirass. ECNP will be maintained at -10 cmH₂O throughout administration and for 10 minutes after. FiO₂ will not be reduced until SpO₂ stabilizes ≥92% and FiO₂ is ≤0.25.",[13],"Procedure: ENCP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","ENCP","Surfactant will be given in two doses within 2 minutes while continuous negative pressure is applied using the Hayek RTX thoracoabdominal cuirass. Negative pressure will be maintained during and for 10 minutes after administration.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ján Hlivák, MUDr.","CONTACT","+420774221805","jan.hlivak@vfn.cz",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Tereza Lamberská, MUDr., PhD.","+420224967404","tereza.lamberska@vfn.cz",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Ján Hlivák","Principal investigator","100613805","external-negative-pressure-during-lisa-100613805",false,"NCT07271368","EXTERNAL NEGATIVE PRESSURE DURING LISA","AN EXTERNAL NEGATIVE PRESSURE USE DURING THE LISA PROCEDURE. A FEASIBILITY STUDY","Inclusion Criteria:\n\n* Preterm infants ≥ 32 weeks of gestational age\n* FiO₂ \\> 0.30 for more than 30 minutes on CPAP (6 - 8 cm H₂O) or HFNC (8 l\u002Fmin)\n* Increased work of breathing despite FiO₂ \\\u003C 0.30\n* Birth weight \\> 800 g\n* X-ray confirmed RDS\n* Availability of all required devices and appropriately fitting cuirass\n\nExclusion Criteria:\n\n* Requirement for endotracheal intubation or mechanical ventilation prior to surfactant administration\n* Major congenital anomalies (cardiac, pulmonary, chromosomal)\n* Known or suspected neuromuscular or metabolic disorders\n* Lack or withdrawal of informed parental consent","ALL","1 Hour","3 Days",{"count":46,"type":47},25,"ESTIMATED","INTERVENTIONAL",[50],"NA","The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS). It will also assess whether ECNP can improve surfactant distribution and reduce procedural complications. The main questions it aims to answer are:\n\nDoes ECNP during LISA improve surfactant distribution and oxygenation in preterm infants with RDS?\n\nDoes ECNP reduce the occurrence of complications such as desaturation, bradycardia, or apnea during the procedure?\n\nDoes ECNP reduce the need for repeated surfactant administration?\n\nResearchers will evaluate ECNP combined with LISA in preterm infants on HFNC or CPAP to see if it improves outcomes compared to standard methods.\n\nParticipants will:\n\nReceive LISA with ECNP support via a soft thoracoabdominal cuirass\n\nBe monitored for procedural complications like desaturation, bradycardia, or apnea\n\nHave their oxygenation levels, surfactant distribution, and need for repeated surfactant doses assessed\n\nPrimary Outcome:\n\nThe procedure will be considered safe if no more than 20% of participants experience serious adverse events, such as apnea requiring positive pressure ventilation or persistent desaturation.\n\nSecondary Outcomes:\n\nCompletion of LISA without interruption due to complications\n\nReduction of FiO₂ to ≤0.25 within 3 hours post-surfactant administration\n\nAvoidance of repeated surfactant doses via the INSURE method",[53],"Neonatology",[55],"LISA, negative pressure, neonatology, preterm, surfactant","NOT_YET_RECRUITING","2025-12-16",{"date":59,"type":60},"2025-12-17","ACTUAL",{"date":62,"type":47},"2025-12-22",{"date":64,"type":47},"2027-01-31",{"name":5,"class":6}]