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EXTERNAL NEGATIVE PRESSURE DURING LISA

NCT07271368 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-17

No results posted yet for this study

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

Conditions

  • Neonatology

Interventions

PROCEDURE

ENCP

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 & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2026-09-30
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271368 on ClinicalTrials.gov