Lung UltrasoundULISSESNCT07070167
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
An observational study of Lung Ultrasound and Respiratory Distress Syndrome, Newborn, run by Chiesi Poland Sp. z o.o. at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Ultrasound, Respiratory Distress Syndrome, Newborn
- What is being tested?
- Intratracheal administration of surfactant
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 30 Aug 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes preterm neonates born before 37 weeks of gestation with diagnosed or suspected Respiratory Distress Syndrome (RDS) who are considered for surfactant (SF) therapy based on the attending physician's judgment. Only infants managed initially without delivery room intubation are eligible, ensuring a baseline lung ultrasound (LUS) can be performed before SF administration. Participants will be recruited from tertiary neonatal intensive care units in Poland, all experienced in neonatal ultrasound.
Who may be able to join
- 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
Who cannot join
- Presence of major congenital abnormalities of the respiratory system
- Infants requiring primary intubation and mechanical ventilation in the delivery room
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Department of Neonatology, Czerwiakowski Hospital at Siemiradzki st., Cracow, Poland
Krakow, 31137
Piotr Kruczek, MD, PhD, +48 12 512 301 447, kruczekpiotr@poczta.onet.pl
Department of Neonatology and Neonatal Intensive Care, Medical University of Warsaw
Warsaw
Renata Bokiniec, Prof., +48 22 596 61 75, renata.bokiniec@wum.edu.pl
About this study
Official title: Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome
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.
Read the 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.
- Being tested
- Intratracheal administration of surfactant
- Keywords
- surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratracheal administration of surfactantDrug
Intratracheal administration of pulmonary surfactant with any of the approved methods: (a) via endotracheal tube in a mechanically-ventilated infant, (b) with the INSURE method (intubation-surfactant-extubation), or (c) with LISA method (through a thin catheter inserted intratracheally in a spontaneously breathing infant, supported with CPAP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of lung ultrasound in treatment decisions
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.
Measured: 1st day of life
Secondary outcomes (1)
Lung aeration asymmetry
Percentage of infants presenting with the side-to-side lung ultrasound score difference ≥2 points at 24 hours after surfactant (SF) administration
Measured: From the time of SF administration to 24 hours (±6 hours) after the dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Poland Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Polish Ultrasound Society, Neonatal Section
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070167
- Sponsor's protocol ID
- CHI-PL-CUR-05
- Acronym
- ULISSES
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the data protection policies of the Principal Investigator's institution, individual participant data (IPD) cannot be shared with external researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07070167
- Acronym / sponsor ID
- ULISSES / CHI-PL-CUR-05
- Keywords
- surfactant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chiesi Poland Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Polish Ultrasound Society, Neonatal Section
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes preterm neonates born before 37 weeks of gestation with diagnosed or suspected Respiratory Distress Syndrome (RDS) who are considered for surfactant (SF) therapy based on the attending physician's judgment. Only infants managed initially without delivery room intubation are eligible, ensuring a baseline lung ultrasound (LUS) can be performed before SF administration. Participants will be recruited from tertiary neonatal intensive care units in Poland, all experienced in neonatal ultrasound.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of major congenital abnormalities of the respiratory system
- Infants requiring primary intubation and mechanical ventilation in the delivery room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intratracheal administration of surfactantIntratracheal administration of pulmonary surfactant with any of the approved methods: (a) via endotracheal tube in a mechanically-ventilated infant, (b) with the INSURE method (intubation-surfactant-extubation), or (c) with LISA method (through a thin catheter inserted intratracheally in a spontaneously breathing infant, supported with CPAP) | Drug | – |
Primary outcome
Adoption of lung ultrasound in treatment decisions
Time frame: 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.
1 secondary outcome
Lung aeration asymmetry
Time frame: From the time of SF administration to 24 hours (±6 hours) after the dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No. In accordance with the data protection policies of the Principal Investigator's institution, individual participant data (IPD) cannot be shared with external researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Ultrasound and Respiratory Distress Syndrome, Newborn, run by Chiesi Poland Sp. z o.o. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Kruczek, MD, PhD (+48 12 634 2601, kruczekpiotr@poczta.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of lung ultrasound in treatment decisions (time frame: 1st day of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.