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EXTERNAL NEGATIVE PRESSURE DURING LISA

Study acronym: ENCP LISA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Sep 30, 2026 → Mar 30, 2027
See other at-risk trials from Charles University, Czech Republic

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 30, 2026 to Mar 30, 2027v3 Show 4 more changesShow less
    • Recruitment opened
    • Study completion pushed from Jan 31, 2027 to Dec 31, 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 22, 2025 to Mar 17, 2025
  2. Minor Start date: Dec 1, 2025 to Dec 22, 2025
    • Study description shortened, about 312 words
    • Study title shortened, about 7 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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: Does ECNP during LISA improve surfactant distribution and oxygenation in preterm infants with RDS? Does ECNP reduce the occurrence of complications such as desaturation, bradycardia, or apnea during the procedure? Does ECNP reduce the need for repeated surfactant administration? Researchers will evaluate ECNP combined with LISA in preterm infants on HFNC or CPAP to see if it improves outcomes compared to standard methods. Participants will: Receive LISA with ECNP support via a soft thoracoabdominal cuirass Be monitored for procedural complications like desaturation, bradycardia, or apnea Have their oxygenation levels, surfactant distribution, and need for repeated surfactant doses assessed Primary Outcome: The 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. Secondary Outcomes: Completion of LISA without interruption due to complications Reduction of FiO₂ to ≤0.25 within 3 hours post-surfactant administration Avoidance of repeated surfactant doses via the INSURE method
Trial Details
NCT Number NCT07271368
Lead Sponsor Charles University, Czech Republic
Conditions
(from sponsor)
Neonatology
Related terms Premature Birth
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov