Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-30 @ 9:25 PM
Study NCT ID:
NCT07070167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
Sponsor:
Chiesi Poland Sp. z o.o.
Organization:
Study Overview
Official Title:
Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULISSES
Brief Summary:
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.
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.
Detailed Description:
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.
Comprehensive clinical data-including gestational age, birth history, comorbidities, oxygenation parameters (SpO₂/FiO₂), and level and duration of respiratory support-will be collected through the neonatal hospital stay. Respiratory support will be categorized into escalating classes from spontaneous breathing to mechanical ventilation, to allow stratified analysis of post-surfactant respiratory outcomes.
The study will also explore associations between post-treatment lung ultrasound asymmetry, mode of surfactant delivery, and the presence of pulmonary comorbidities using multivariable logistic regression modeling.
All data will be collected in accordance with good clinical practice and applicable data protection regulations. As a non-interventional study, ULISSES is intended to provide evidence on the integration of bedside imaging into neonatal care, without altering routine clinical management.
The planned study duration is from end-July 2025 to December 2026.
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.
Comprehensive clinical data-including gestational age, birth history, comorbidities, oxygenation parameters (SpO₂/FiO₂), and level and duration of respiratory support-will be collected through the neonatal hospital stay. Respiratory support will be categorized into escalating classes from spontaneous breathing to mechanical ventilation, to allow stratified analysis of post-surfactant respiratory outcomes.
The study will also explore associations between post-treatment lung ultrasound asymmetry, mode of surfactant delivery, and the presence of pulmonary comorbidities using multivariable logistic regression modeling.
All data will be collected in accordance with good clinical practice and applicable data protection regulations. As a non-interventional study, ULISSES is intended to provide evidence on the integration of bedside imaging into neonatal care, without altering routine clinical management.
The planned study duration is from end-July 2025 to December 2026.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: