Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
Launched by ASST FATEBENEFRATELLI SACCO · Nov 3, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the best way to help premature infants who have breathing difficulties right after birth, specifically those with a condition called Respiratory Distress Syndrome (RDS). The researchers want to see if using a special breathing support technique called CPAP (Continuous Positive Airway Pressure) at a higher pressure of 8 cmH2O can help improve the infants' lung function better than a lower pressure of 5 cmH2O. They are looking at whether better lung function in the early minutes of life can lead to healthier outcomes for these babies in the long run.
To be part of this trial, infants need to be born between 26 and 29 weeks of pregnancy and have RDS requiring noninvasive help with their breathing. Infants with certain birth defects will not be eligible. If a baby joins the study, their doctors will closely monitor how well they breathe with the different pressure levels during their first moments after birth. This research aims to find the best care for these vulnerable newborns to give them a stronger start in life.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support
- Exclusion Criteria:
- • Congenital anomalies
About Asst Fatebenefratelli Sacco
Asst Fatebenefratelli Sacco is a prominent healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong commitment to ethical standards and patient safety, the organization collaborates with leading researchers and healthcare professionals to explore new therapies and treatment options across various medical fields. Asst Fatebenefratelli Sacco leverages its extensive expertise and state-of-the-art facilities to contribute to the global body of medical knowledge, ultimately aiming to enhance the quality of care for patients both locally and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, Lombardy, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported