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
Qualifiers
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 design
Treatments tested in this trial
- Intratracheal administration of surfactant
Treatment groups
No treatment groups listed
Sponsors and collaborators
Chiesi Poland Sp. z o.o.
Lead sponsor
Polish Ultrasound Society, Neonatal Section
Collaborator
Source ClinicalTrials.gov