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EXTERNAL NEGATIVE PRESSURE DURING LISA

RecruitingNAAges 1 Hour - 3 DaysAllCharles University, Czech Republic
NCT07271368 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 supp

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📋 Eligibility rules (as published)
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
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What it tests

  • ENCP
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Where

1 site
Klinika gynekologie, porodnictví a neonatologie
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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