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RECRUITING Not applicable ClinicalTrials.gov

EXTERNAL NEGATIVE PRESSURE DURING LISA

Sponsor: Charles University, Czech Republic • ClinicalTrials.gov ID: NCT07271368

Registry updated: 2026-08-21
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Description

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

Interventions

  • ENCP (Procedure)
    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.

Eligibility criteria

Inclusion Criteria: * Preterm infants ≥ 32 weeks of gestational age * FiO₂ \> 0.30 for more than 30 minutes on CPAP (6 - 8 cm H₂O) or HFNC (8 l/min) * Increased work of breathing despite FiO₂ \< 0.30 * Birth weight \> 800 g * X-ray confirmed RDS * Availability of all required devices and appropriately fitting cuirass Exclusion Criteria: * Requirement for endotracheal intubation or mechanical ventilation prior to surfactant administration * Major congenital anomalies (cardiac, pulmonary, chromosomal) * Known or suspected neuromuscular or metabolic disorders * Lack or withdrawal of informed parental consent

Conditions

Neonatology

Locations

  • Klinika gynekologie, porodnictví a neonatologie — Prague, Praha 2, Czechia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record