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NOT YET RECRUITING
NCT07070167

Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant

Sponsor: Chiesi Poland Sp. z o.o.

View on ClinicalTrials.gov

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.

Official title: Point-of-Care Ultrasonography for Assessing Lung Aeration and Pulmonary Vascular Resistance Dynamics After Surfactant Administration in Neonates With Respiratory Distress Syndrome

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-08-30

Completion Date

2026-12-30

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

DRUG

Intratracheal administration of surfactant

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)

Locations (2)

Department of Neonatology, Czerwiakowski Hospital at Siemiradzki st., Cracow, Poland

Krakow, Poland

Department of Neonatology and Neonatal Intensive Care, Medical University of Warsaw

Warsaw, Poland