EXTERNAL NEGATIVE PRESSURE DURING LISA
ConditionNeonatology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorCharles University, Czech Republic
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ENCP
Procedure/SurgerySurfactant 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: ENCP LISAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the procedure
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.
Time frame
15 minutesSecondary outcomes
1
Completion of the LISA procedure without interruption
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.
Time frame
3 hoursSponsors and contacts
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Source ClinicalTrials.gov