Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
Launched by CHIESI POLAND SP. Z O.O. · Jul 15, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how doctors can use bedside ultrasound—a safe, painless imaging test done right at the baby’s bedside—to better care for premature newborns who have trouble breathing due to a condition called Respiratory Distress Syndrome (RDS). The study is looking at whether using ultrasound images of the lungs, along with oxygen levels, can help doctors decide when and how to give a medicine called surfactant, which helps the baby’s lungs work better. Some babies will also have their heart and lung blood flow checked to see if there are signs of high blood pressure in the lungs.
The trial will include about 200 premature babies born before 37 weeks of pregnancy who have or might develop RDS. Babies with major lung abnormalities or those needing immediate breathing machines right after birth won’t be included. During the study, doctors will perform ultrasound scans before and after giving surfactant to see how both lungs respond and if this affects the baby’s need for breathing support. The goal is to find better ways to treat newborns with breathing problems and improve their care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Presence of major congenital abnormalities of the respiratory system
- • Infants requiring primary intubation and mechanical ventilation in the delivery room
About Chiesi Poland Sp. Z O.O.
Chiesi Poland sp. z o.o. is a leading pharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. As a subsidiary of the Chiesi Group, an international healthcare organization headquartered in Italy, Chiesi Poland focuses on enhancing patient outcomes through advanced respiratory, specialty care, and rare disease medications. Committed to scientific excellence and ethical practices, the company actively engages in clinical trials to further its mission of improving health and quality of life. With a strong emphasis on collaboration and sustainability, Chiesi Poland aims to be at the forefront of medical advancements in Poland and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kraków, , Poland
Warszawa, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported