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

NCT07070167 | Not Yet Recruiting

• 1 other identifier: CHI-PL-CUR-05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Ultrasound; Respiratory Distress Syndrome, Newborn

Keywords

surfactant

Outcome Measures

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.

  1st day of life

Secondary Outcomes (1)

• Lung aeration asymmetry

  From the time of SF administration to 24 hours (±6 hours) after the dose

Other Outcomes (1)

• Vascular resistance in the pulmonary circulation.

  From the time of SF administration to 24 hours (±6 hours) after the dose

Interventions

Intratracheal administration of surfactant DRUG

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Presence of major congenital abnormalities of the respiratory system
• Infants requiring primary intubation and mechanical ventilation in the delivery room

Sponsors & Collaborators

• Chiesi Poland Sp. z o.o.: lead
• Polish Ultrasound Society, Neonatal Section: collaborator

Study Sites (2)

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

Krakow, 31137, Poland

Location

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

Warsaw, Poland

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Piotr Kruczek, MD, PhD

CONTACT

+48 12 634 2601; kruczekpiotr@poczta.onet.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 17, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)