Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Adoption of lung ultrasound in treatment decisions
研究概览
简要总结
The ULISSES study looks at how doctors use bedside ultrasound to help treat premature babies with breathing problems caused by Respiratory Distress Syndrome (RDS). It focuses on whether doctors decide to give a medicine called surfactant based on oxygen levels alone or if they also use lung ultrasound images to guide their decision.
Around 200 babies will take part in the study in hospitals across Poland. Doctors will do ultrasound scans of the babies' lungs before and after surfactant is given. In some hospitals, heart and lung blood flow will also be checked to look for signs of high blood pressure in the lungs.
The study will see if both lungs improve equally after treatment or if one side stays worse, and whether this affects how much breathing support the baby needs. The results may help doctors improve how and when they give surfactant, leading to better care for newborns with RDS.
详细描述
The ULISSES study (Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome) is a prospective, multicenter, non-interventional (observational) study involving approximately 200 preterm neonates across 10-12 tertiary-level neonatal intensive care units (NICUs) in Poland.
The study is designed to evaluate real-world practices related to the use of point-of-care lung ultrasound (LUS) in the decision-making process for surfactant therapy in neonates with Respiratory Distress Syndrome (RDS). The investigation is aligned with evolving European neonatal care guidelines that recommend incorporating LUS findings alongside traditional oxygen thresholds (FiO₂) when determining surfactant need.
All enrolled neonates will undergo a baseline lung ultrasound within the first 6 hours of life, prior to surfactant administration. LUS scoring will follow a validated 5-point scale (0-4) per lung quadrant, resulting in a total score between 0-16. A second LUS examination will be performed between 24 and 30 hours after surfactant administration to assess treatment response and identify any asymmetry in lung aeration, defined as a side-to-side LUS score difference ≥2 points.
In a subset of centers that routinely conduct neonatal hemodynamic assessments, echocardiographic evaluation of the main pulmonary artery (MPA) and ascending aorta (AA) diameters will be carried out. The MPA-to-AA ratio will serve as a surrogate marker of pulmonary vascular resistance and potential pulmonary hypertension. A ratio >1.3 will be considered indicative of clinically significant pulmonary arterial hypertension, consistent with published literature.
The surfactant treatment (product: Curosurf) will be administered per standard clinical practice, including both LISA (Less Invasive Surfactant Administration) and INSURE (INtubation, SURfactant administration, Extubation) methods. The mode of surfactant delivery and timing of administration will be recorded, as will any need for redosing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates (gestational age <37 weeks) with established Respiratory Distress Syndrome (RDS) or at risk for RDS
- •Decision of the use of surfactant by the attending physician
排除标准
- •Presence of major congenital abnormalities of the respiratory system
- •Infants requiring primary intubation and mechanical ventilation in the delivery room
结局指标
主要结局
Adoption of lung ultrasound in treatment decisions
时间窗: 1st day of life
The rate of surfactant treatment decisions based on lung ultrasound score (LUS)\* versus those based on oxygen requirement\*\*. \*Definition of LUS-guided treatment: LUS score ≥6 points and FiO2 ≤0.30 before surfactant administration; \*\*Definition of FiO2-guided treatment:: FiO2 \>0.30, regardless of LUS score value before surfactant administration.
次要结局
- Lung aeration asymmetry(From the time of SF administration to 24 hours (±6 hours) after the dose)