External negative pressure during lighter-invasive surfactant administration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study examines the safety and potential effectiveness of using external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome who are supported by non-invasive ventilation. ECNP is applied via a soft cuirass to promote more uniform lung inflation and potentially improve surfactant distribution. The study is single-arm and focuses on feasibility, safety, and preliminary signals of benefit, including improved oxygenation and fewer procedure-related complications. Outcomes include the rate of desaturation, bradycardia, apnea, and need for repeat surfactant dosing. Eligible infants are monitored closely during the LISA procedure to assess any adverse events and procedural feasibility.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinika gynekologie, porodnictví a neonatologie
  Prague, Praha 2, Czechia Recruiting

Study contacts

• Study coordinator: Ján Hlivák, MUDr.
• Email: jan.hlivak@vfn.cz
• Phone: +420774221805

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.