AN EXTERNAL NEGATIVE PRESSURE USE DURING THE LISA PROCEDURE. A FEASIBILITY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety of the procedure
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ENCP LISA
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.
干预措施: ENCP (Procedure)
结局指标
主要结局
Safety of the procedure
时间窗: 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.
Safety of the procedure
时间窗: 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.
次要结局
- Completion of the LISA procedure without interruption(3 hours)
研究者
Ján Hlivák
Principal investigator
Charles University, Czech Republic