Neonatology
Conditions
Keywords
LISA, negative pressure, neonatology, preterm, surfactant
Brief summary
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
Detailed description
This pilot study evaluates 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) supported by non-invasive respiratory support. ECNP, delivered via a modern negative-pressure ventilation device and a soft thoracoabdominal cuirass, generates a sustained sub-atmospheric pressure around the chest wall. This mode of support is intended to facilitate spontaneous breathing, promote more homogeneous lung inflation, and potentially enhance the distribution of intratracheally delivered surfactant. LISA using thin catheters is a widely adopted method for surfactant administration in spontaneously breathing neonates receiving CPAP or HFNC. Although effective, the procedure is frequently complicated by transient hypoxemia, bradycardia, apnea, and surfactant reflux, occasionally requiring temporary interruption or conversion to more invasive therapy. These complications may impair surfactant delivery, contribute to uneven lung aeration, and lead to the need for repeated dosing. To date, the integration of continuous negative-pressure support during LISA has not been evaluated in clinical practice. In this single-arm feasibility study, ECNP will be initiated shortly before and maintained throughout the LISA procedure. The study will assess whether negative-pressure support stabilizes spontaneous ventilation, improves oxygenation, and facilitates more uniform surfactant distribution during administration. Safety will be evaluated based on the occurrence of serious procedure-related events requiring interruption, such as significant desaturation, bradycardia, or apnea requiring positive-pressure ventilation. Effectiveness will be explored through measures of post-procedure oxygenation stability, need for repeat surfactant dosing, and indicators of adequate surfactant distribution (e.g., imaging assessments when clinically indicated). This exploratory study is designed to inform the potential utility of ECNP as an adjunct during LISA and to determine whether a larger controlled trial is warranted. The protocol focuses on documenting feasibility (ability to complete LISA under ECNP), characterizing physiologic responses, and capturing any adverse events specifically associated with ECNP use in this population
Interventions
PROCEDUREENCP
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.
Sponsors
Charles University, Czech Republic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Infants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L/min) 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/kg) 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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the procedure | 15 minutes | No more than 20% of neonates experience serious adverse events requiring procedural interruption. Serious adverse events: * apnea necessitating positive pressure ventilation (PPV) or intubation * persistent desaturation (SpO₂ \< 80%) unresponsive to increased FiO₂ * prolonged bradycardia (heart rate \< 100 bpm) requiring interruption of the procedure * any other adverse event or treatment failure leading to the need for a repeated surfactant administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the LISA procedure without interruption | 3 hours | Completion of the LISA procedure without interruption due to desaturation, bradycardia, or apnea, and reduction of FiO₂ to ≤0.25 within 3 hours after surfactant administration. |
Countries
Czechia
Contacts
CONTACTJán Hlivák, MUDr.
CONTACTTereza Lamberská, MUDr., PhD.
Outcome results
None listed