Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChiesi Poland Sp. z o.o.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of major congenital abnormalities of the respiratory system
Infants requiring primary intubation and mechanical ventilation in the delivery room
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intratracheal administration of surfactant
DrugIntratracheal 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)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1st day of lifeSecondary 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
Time frame
From the time of SF administration to 24 hours (±6 hours) after the doseOther outcomes
1
Vascular resistance in the pulmonary circulation.
Changes in the Main Pulmonary Artery to Ascending Aorta ratio (MPA-to-AA) at 24 hours post-surfactant (SF) compared to pre-SF value
Time frame
From the time of SF administration to 24 hours (±6 hours) after the doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chiesi Poland Sp. z o.o.
Lead sponsor
Polish Ultrasound Society, Neonatal Section
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: